Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1650907

FEI Number

3002681132

Entity Name

Isomedix Operations Inc.

City/State/Country

GRAND PRAIRIE, TX, US

Establishment Address

1175 Isuzu Pkwy, GRAND PRAIRIE, TX 75050, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 9072619)

Owner / Operator Contact Address

5960 Heisley Road, --, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StrykerSustainability (GP) - Reprocessed Powered Patient Transfer Device Johnson & Johnson (GP) - Band-Aid Insulet5490 (PL) - PodPals Adhesive Overlay Insulet5490 (PL) - Adhesive Overlay J&J2483 (GP) - Band-Aid Intuitive5779 (SDA,GP) - 19G Biopsy Needle Intuitive5779 (SDA,GP) - Vision Probe Adapter Intuitive5779 (SDA,GP) - 21G Biopsy Needle Intuitive5779 (SDA,GP) - 23GBiopsy Needle Intuitive5779 (SDA,GP) - Swivel Connector Medivators2752 (GP) - Defendo Cleaning Adapter Ethicon (SDA,GP) - ETHICONTM 4000 45mm Stapler Ambu10292 (GP) - aScope 4 Broncho Large 5.8/2.8 Ambu aScope 4 Broncho Regular 5/2.2 Ambu aScope 4 Broncho Slim 3.8/1.2 Civco3930 (GP) - omniTRAX(TM) Active Patient Tracker Intuitive5779 (SDA,GP) - Xi 8mm Synchroseal Ambu10292 (GP) - Ambu aScope 4 RhinoLaryngo Slim Ethicon (SDA,GP) - ETHICON 4000 Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Civco3930 (GP) - Disposable Template Civco3930 (GP) - Verza Needle Guide Intuitive5779 (SDA,GP) - MCS Tip Cover Intuitive5779 (SDA,GP) - Stapler Sheath J&J2483 (GP) - Band-Aid StrykerSustainability (GP) - Reprocessed HARMONIC 1100 Shears Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Intuitive5779 (SDA,GP) - Xi Single-Site Cannula Seal Intuitive5779 (SDA,GP) - Xi Single-Site Port Intuitive5779 (SDA,GP) - Xi Single Site Bipolar Maryland Intuitive_5779 (SDA,GP) - Xi Vessel Sealer Extend DORC10527 (PL) - Phacoemulsification / Vitrectomy System Ambu10292 (GP) Ambu aScope 4 Cysto Civco3930 (GP) - PROCover StrykerSustainability (GP) - Reprocessed HARMONIC 700 Shears Ambu10292 (GP) - Ambu aScope 4 RhinoLaryngo Intervention Intuitive5779 (SDA,GP) - Si Cannula Seal Intuitive_5779 (SDA,GP) - 8mm Stapler Medivators2752 (GP) - SCISSORS INSERT, HOOK, 45CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, CVD METZ, 45CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, HOOK, 36CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, MINI METZ, 45CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, CVD METZ, 36CM, 10/BOX Medivators2752 (GP) - SCISSORS INSERT, MINI METZ, 36CM, 10/BOX Intuitive5779 (SDA,GP) - Xi Harmonic ACE BioMed3889 (PL) - Rylon-1 J&J2483 (GP) - Band-Aid; Johnson & Johnson Red Cross Medivators2752 (GP) - DEFENDO Air/Water/Suction and Biopsy Valves and Kits (1003xx); DEFENDO Valve and Connector Kit Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical StrykerSustainability (GP) - Reprocessed Endoscopic Trocars and Sleeves Medivators2752 (GP) - Endogator Irrigation Pump Model EGP-100 Ethicon (SDA,GP) - Electrosurgical, Cutting & Coagulation & Accessories Civco3930 (GP) - L25 Series Needle Guide Civco3930 (GP) - Neoguard Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Medivators2752 (GP) - SWITCH-BLADEMINI-METZENBAUM SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADEHOOK SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADESTRAIGHT METZENBAUM SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADE CURVED METZENBAUM SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADEMINI METZENBAUM CLICK-FIT SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADESTRAIGHT METZENBAUM CLICK-FIT SCISSOR TIP Medivators2752 (GP) - SWITCH-BLADECURVEDMETZENBAUM CLICK-FIT SCISSOR TIP Medivators2752 (GP) - DEFENDO AirWater Suction Valve DEFENDO AirWaterSuction Biopsy Valve DEFENDO Valve Connector Kit StrykerSustainability (GP) - Reprocessed Compression Sleeve StrykerSustainability (GP) - Reprocessed Compression Sleeves Intuitive5779 (SDA,GP) - Si Harmonic ACE Insert Medivators2752 (GP) - Endo Smartcap Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical StrykerSustainability (GP) - Reprocessed MyoSure LITE Tissue Removal Device StrykerSustainability (GP) - Reprocessed MyoSure XL Tissue Removal Device for Fluent StrykerSustainability (GP) - Reprocessed MyoSure REACH Tissue Removal Device StrykerSustainability (GP) - Reprocessed MyoSure XL Tissue Removal Device StrykerSustainability (GP) - Reprocessed MyoSure Tissue Removal Device Intuitive5779 (SDA,GP) - Xi Column Drape Intuitive5779 (SDA,GP) - Xi Instrument Arm Drape Ethicon (SDA,GP) - Staple, Implantable StrykerSustainability (GP) - REPROCESSED DILATING TIP TROCARS StrykerSustainability (GP) - Reprocessed Compression Sleeve Intuitive5779 (SDA,GP) - Xi Single Site Fenestrated Bipolar Forceps Ethicon (SDA,GP) - Surgical Stapler StrykerSustainability (GP) - Reprocessed Nellcor Pulse Oximeter Sensor Civco3930 (GP) - Active Fiducial Marker; EMT System; eTRAX Needle System; eTRAX Variable Angle Needle Guide Civco3930 (GP) - General Purpose Sensor; ViruTRAX Instrument Navigator Intuitive5779 (SDA,GP) - IS4200 Arm 4 Proximal Drape Protech3048 (GP) - 7894-6 - LEVO STERILE CERVICAL DRAPE W/WINDOW 6CS Protech3048 (GP) - 6855AUD-6 - HANA ANTERIOR HIP UPPER STERILE DRAPE, 6 Civco3930 (GP) - Envision Medivators2752 (GP) - Endo Gator Hybrid Tubing Kits Medivators2752 (GP) - Defendo Y-Opsy Irrigator Intuitive5779 (GP,SDA) - Xi Stapler 45 Reload

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-06-24
FRZ	Device, Patient Transfer, Powered	General Hospital	Class 2	880.6775	2023-09-28
QDY	Vitrectomy Kit	Ophthalmic	Class 2	886.4150	2025-09-22
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2018-05-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-07
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2012-12-17
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2012-12-17
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-12-17
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2012-12-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-11-16
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-06-02
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2012-12-20
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-06-22
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2021-01-05
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2021-01-05
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2021-01-05
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-01-08
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-12-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-12-23
QDV	Iol Tray	Ophthalmic	Class 1	886.4350	2025-09-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-06-23
HQB	Photocoagulator And Accessories	Ophthalmic	Class 2	886.4690	2024-12-19
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-12-19
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-12-19
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-12-19
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2020-01-23
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-08-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-08-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-08-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-06-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-06-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-08-05
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-06-02
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-04-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-04-12
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-08-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-08-05
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-08-05
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-05-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-05-21
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2012-12-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2025-08-04
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2025-08-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-08-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-06-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-06-02
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-06-02
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2012-12-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-06-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-08-04
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2012-12-17
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2026-04-02
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2012-12-17
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unknown	Class U	N/A	2017-04-12
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-08-05
FHM	Apparatus, Suturing, Stomach And Intestinal	General, Plastic Surgery	Class 1	878.4800	2025-08-04
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2020-01-23
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2013-06-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-06-22
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2012-12-17
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-06-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-02
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-06-05
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2013-06-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-08-25
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unknown	Class U	N/A	2025-08-25
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2012-12-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2020-01-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2012-12-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-10-30
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-04-08
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-04-12
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2020-01-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unknown	Class U	N/A	2025-08-25
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-04-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-04-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-10-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-10-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-06-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-11-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-06-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-06-24
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2024-04-08
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unknown	Class U	N/A	2014-05-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-06-22
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2012-12-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-12-20
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-12-17
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2012-12-17
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2012-12-17
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2013-06-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-10-30
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2020-10-30
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2013-06-24
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2023-03-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-03-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-08-05
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-06-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-06-21
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-04-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-11-24
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2012-10-30
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-06-24
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-06-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2024-12-19
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2012-12-17
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2018-04-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-04-23
QDW	Phaco Kit	Ophthalmic	Class 2	886.4670	2025-09-22
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2020-10-07
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2025-09-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-03-24
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2014-07-29
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-11-06
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-09-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-06-24
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2021-11-09
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2021-11-09
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2021-11-09
NLF	Oximeter, Reprocessed	Cardiovascular	Class 2	870.2700	2013-06-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-08-04
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-06-02
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-08-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-06-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-02
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2013-06-24
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-01-08
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-03-10
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-08-04
ODX	Autonomous Extracorporeal Blood Leak Detector/Alarm	Gastroenterology, Urology	Class 2	876.5820	2020-01-23
ONW	Hemodialysis System For Home Use	Gastroenterology, Urology	Class 2	876.5860	2020-01-23
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2013-06-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-06-24
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2020-01-23
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-02-26
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unknown	Class U	N/A	2024-02-26
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2012-12-17
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2013-06-24

Official Correspondent

No official correspondent registered.

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Related Public Records

Same Entity

STERIS Corporation

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

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-2096-2017	Abbott Medical Optics Inc. (AMO)	2	AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Z-0304-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-2108-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1650907. Last updated year: 2026. Please use registration number 1650907 when referencing this establishment in official correspondence.