Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2320762

FEI Number

3003040625

Entity Name

DEROYAL INDUSTRIES, INC.

City/State/Country

NEW TAZEWELL, TN, US

Establishment Address

1595 Highway 33 S, NEW TAZEWELL, TN 37825, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)

Owner / Operator Contact Address

200 DEBUSK LN., --, Powell, TN 37849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032676

PMA Number

N/A

All Registered Proprietary Names

Container, Specimen Mailer and Storage, Sterile - DeRoyal Dressing, Wound, Drug - DeRoyal Tubing, Noninvasive - DeRoyal Absorber, Saliva, Paper - DeRoyal Catheter, Urological - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Electrode Electrocardiograph - DeRoyal Tubing, Pressure and Accessories - DeRoyal Container, Specimen, Sterile - DeRoyal Tissue Adhesive for the Topical Approximation of Skin - DeRoyal Dressing, Wound, Drug - DeRoyal Multidex Laparoscope, General & Plastic Surgery - DeRoyal Clamp, Vascular - DeRoyal Accessories, Catheter - DeRoyal Dressing, Wound, Drug - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Insufflator, Laparoscopic - DeRoyal Light, Surgical, Accessories - DeRoyal Introducer, Catheter - DeRoyal Syringe, Irrigating (Non Dental) - DeRoyal Burn Kit without Drug - DeRoyal Pro-II NPWT Powered Suction Pump, Collection canisters, hoses, Y-connectors & tubing, and foam/gauze dressings DeRoyal Transducer, Pressure, Catheter Tip - DeRoyal Saline, Vascular Access Flush - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Set, Administration, Intravascular - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Needle, Aspiration and Injection, Disposable - DeRoyal Catheter, Intravascular, Therapeutic, Short-term Less than 30 days - DeRoyal Body Fluid Barrier Kit - DeRoyal Catheter, Urological - DeRoyal Accessory, Surgical Apparel - DeRoyal MICROSCOPE SLIDES - DeRoyal Wax, Bone - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Syringe, Piston - Needle, Hypodermic, Single Lumen - DeRoyal Neurosurgical Paddie - DeRoyal Eye Tray - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Set, Administration, Intravascular - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Drape, Surgical - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Scissors, Medical, Disposable - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Connector, Catheter - DeRoyal Dressing, Wound, Occlusive - DeRoyal Pad, Eye - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Tray, Surgical - DeRoyal Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic - DeRoyal Multidex Set, Administration, Intravascular - DeRoyal Cover, Barrier, Protective - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal Drape, Surgical - DeRoyal Cardiovascular Surgical Instruments Tray - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Anesthesia Breathing Circuit Kit (Adult & Pediatric) - DeRoyal Sponge, Ophthalmic - DeRoyal Gauze/Sponge, Internal - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Table, Cysto, Non-Electrical - DeRoyal Stapler, Skin - DeRoyal Restraint, Protective - DeRoyal Connector, Catheter - DeRoyal Clean-up Kit - DeRoyal Staple, Removeable (Skin) - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Gynecological Laparoscopic Kit - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Dressing, Wound, Drug - DeRoyal Drape, Surgical - DeRoyal Clip, Implantable - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Hemostat - DeRoyal Catheter, Urological - DeRoyal Device, Occlusion, Umbilical - DeRoyal IMD - Pack, Hot or Cold, Disposable - DeRoyal Garment, Protective, for Incontinence - DeRoyal Gown, Surgical - DeRoyal Laryngoscope, Endoscope - DeRoyal Drape, Surgical - DeRoyal Tray, Surgical, Instrument - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Dressing Change Tray - DeRoyal Bandage, Cast - DeRoyal Catheter, Urological (antimicrobial) and Accessories - DeRoyal Foley Catheter Kit (excludes HIV testing) - DeRoyal Syringe, Piston - DeRoyal Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Lubricant, Patient - DeRoyal Container, I. V. - DeRoyal Syringe, Piston - DeRoyal Catheter, Urological - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal CLAMP - DeRoyal Airway, Oropharyngeal, Anesthesiology - DeRoyal Syringe, Periodontic, Endodontic, Irrigating - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Forceps, General & Plastic Surgery - DeRoyal Instrument, Ligature Passing & Knot Typing - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Handle, Scalpel - DeRoyal Wax, Bone - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Set, Administration, Intravascular - DeRoyal Protector, Skin Pressure - DeRoyal Gas Mask-Anesthesia - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Drape, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Kit, Wound Dressing - DeRoyal Catheter and Tip, Suction - DeRoyal Filter, Bacterial, Breathing - Circuit - DeRoyal Razor, Surgical - DeRoyal Staple, Removable (Skin) - DeRoyal Lift, Patient, Non-AC-Powered - DeRoyal Lavage, Jet - DeRoyal Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Clamp, Surgical, General & Plastic Surgery - DeRoyal Balloon, Epistaxis - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Gauze/Sponge, Internal - DeRoyal Gown, Surgical - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Speculum, Vaginal, Nonmetal - DeRoyal Streamway Needle, Conduction, Anesthetic (w/wo Introducer)- DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Set, Administration, Intravascular - DeRoyal Bag, Reservoir - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Tape, Measuring, Rulers and Calipers - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Stopcock, IV Set - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Syringe, Piston - DeRoyal Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Syringe, Piston - DeRoyal Tubing, Pressure and Accessories - DeRoyal Drape, Surgical, Exempt - DeRoyal Solvent, Adhesive Tape - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Apparatus, Suction, Operating-Room, Wall Vacuum Powered - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Drape, Surgical - DeRoyal Specula, Ophthalmic - DeRoyal System, Thermal Regulating - DeRoyal Amniotome - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Mask, Oxygen - DeRoyal Cotton, Roll - DeRoyal Cannula, Manipulator/Injector, Uterine - DeRoyal Device, Specimen Collection - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Clip, Implantable - Add Basin, Emesis - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Sound, Uterine - DeRoyal Pad, Menstrual, Unscented - DeRoyal Catheter, Continuous Irrigation - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Tape and Bandage, Adhesive - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Aspiration Tray (Kit) - DeRoyal Ortho Manual Surgical Instrument - DeRoyal Depressor, Tongue, Non-Surgical - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Accessories, Catheter - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Gown, Surgical - DeRoyal Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - DeRoyal Catheter, Retention Type, Balloon - DeRoyal Catheter and Tip, Suction - DeRoyal Component, Traction, Non-Invasive - DeRoyal General surgery tray - DeRoyal Tubes, Vacuum Sample, with Anticoagulant - DeRoyal Drape, Surgical - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Silver Alginate Cath Patch Dressing - DeRoyal Apparatus, Exhaust, Surgical - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Cannula Vial Access - DeRoyal Support, Patient Position - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Dressing, Wound, Drug - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Bandage, Liquid, Skin Protectant - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Stopcock, IV Set - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Cover, Limb - DeRoyal Catheter, Urological - DeRoyal Syringe, Piston - DeRoyal Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal Marker, Skin - DeRoyal Laparoscope, Gynecologic (and accessories) - DeRoyal Dressing, Wound, Drug, Lavage, Jet - DeRoyal Catheter, Urethral - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Applier, Surgical, Clip - DeRoyal Pap Smear Kit - DeRoyal Tubing, Noninvasive - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Drape, Surgical - DeRoyal Hemostat, Surgical - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Tourniquet Kit - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2001-11-28
SEL	Securement Wound Dressing For Reduction Of Infection	Unknown	Class U	N/A	2024-12-13
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-12-13
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-11-14
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2015-11-10
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-09-28
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2024-12-13
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2004-11-03
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2004-03-03
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2022-08-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-08-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-13
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-11-09
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2004-06-23
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-07-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-01-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-01-15
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-01-15
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-15
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-01-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-01-15
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-01-15
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2024-12-13
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2024-12-13
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2015-09-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-01-20
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1997-10-23
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2015-12-10
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2014-05-15
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2022-01-26
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2024-01-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-05
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2009-08-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-05-12
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-05-24
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2016-02-08
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2004-07-12
MTJ	Wax, Bone	Unknown	Class U	N/A	2016-02-08
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2001-08-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-05-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-05-22
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2016-01-27
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2017-07-31
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-05-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-12
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-01-02
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2001-08-03
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1998-08-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-09-25
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-01-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-13
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-02-06
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2010-08-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2011-09-19
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-01-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-23
OFA	Cardiovascular Surgical Instruments Tray	Cardiovascular	Class 1	870.4500	2021-05-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2016-03-07
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2015-09-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-12-24
EYH	Table, Cysto, Non-Electrical	Gastroenterology, Urology	Class 1	876.4890	2012-09-25
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2022-04-06
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2015-09-15
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-05-24
PWU	Clean-Up Kit	General Hospital	Class 1	880.6890	2021-08-11
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2024-05-24
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-08-28
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2016-03-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-20
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-12-13
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2014-08-01
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2006-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-18
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2006-08-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-12-13
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-02-12
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-05-18
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-01-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-12-13
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-01-20
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-05-16
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-05-24
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-12-10
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2005-08-08
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-08-06
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2024-08-06
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2018-01-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2005-06-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-16
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2015-09-17
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-01-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-09-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-12-17
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-10-06
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2006-08-22
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2012-09-28
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2017-07-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2004-12-09
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-06-03
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-09-17
MTJ	Wax, Bone	Unknown	Class U	N/A	2025-01-20
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2005-08-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-04
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-27
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2004-06-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-27
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-05-24
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2024-01-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1994-01-04
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2015-12-10
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-12-13
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-11-14
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-20
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	1991-07-15
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-12-13
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2011-12-30
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2021-07-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-07-21
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-23
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2016-01-13
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-11-03
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2012-09-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-02-10
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2004-06-23
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2015-09-17
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2025-05-14
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2015-11-10
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-13
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2012-09-28
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-12-13
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2006-08-22
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-12-24
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-05-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-01-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-09-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-09-20
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-01
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2016-02-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2006-08-22
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2013-02-15
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-08-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-12-13
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-05-17
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-12-13
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2001-08-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-13
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-01-13
EFN	Cotton, Roll	Dental	Class 1	872.6050	2004-10-15
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2024-12-13
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2025-08-06
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2020-11-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-05-23
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-05-23
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2001-05-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-24
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-05-24
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2012-09-25
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-11-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-04-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
OJT	Aspiration Tray	General, Plastic Surgery	Class 1	878.4800	2016-05-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-08-10
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2001-08-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-05-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-01
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-09-28
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-05-24
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2012-09-20
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2006-08-22
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-03-07
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2012-09-17
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-14
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2007-12-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-28
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2016-01-14
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-08-22
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2016-03-07
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2005-08-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-28
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-11-02
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-08-15
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2016-02-08
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-09-22
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-05-23
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	1997-02-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2012-09-17
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2001-08-03
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2023-09-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-14
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2012-09-26
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2006-08-22
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-12-13
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-07-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-07-17
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2021-11-04
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-05-10
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2024-01-18
OHL	Pap Smear Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-03-07
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2005-06-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-28
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-24
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2024-05-02
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2012-09-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-12-13
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2016-02-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-01-18

Official Correspondent

Elizabeth Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008583452	DeRoyal Industries, Inc.	Powell, TN, US
1051550	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
1057404	DeRoyal Industries, Inc.	POWELL, TN, US
1034876	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
3021190810	DePre, LLC	Powell, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3027605742	Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, CN
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3044466317	MEDINOVA GROUP CO.	Laguna Beach, CA, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3009526936	CGN Huaray Technology Co., Ltd. Suzhou Branch	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2320762. Last updated year: 2026. Please use registration number 2320762 when referencing this establishment in official correspondence.