Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1528319

FEI Number

1000122656

Entity Name

UNITED STATES ENDOSCOPY GROUP, INC.

City/State/Country

Mentor, OH, US

Establishment Address

5976 Heisley Rd, Mentor, OH 44060, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STERIS Corporation (Owner Number: 10078069)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122462

PMA Number

N/A

All Registered Proprietary Names

Padlock Clip Defect Closure System (C910001) (EN-MF) Padlock Clip Pro-Select Defect Closure System (C913131) (EN-MF) Fuji 700 4-piece Valve Kit (100340) gi4000 Electrosurgical Generator (G1110001, G1110022) (EN-SD) Argon Gas Canister (G1120010) (EN-SD) GoCart (G1112003) (EN-SD) DIN 477 High Pressue Hose for CO2 (390513) (EN-SD) CO2MPACT ENDOSCOPIC INSUFFLATOR (710300) (EN-SD) High Pressure DISS Hose for CO2 (710604) (EN-SD) High Pressure Hose & Yoke for CO2 (710603) (EN-SD) Defendo Fujifilm 700 series valve kits Guardus Overtube - Gastric (00711148, 00711149) (EN-MF) Guardus Overtube - Esophageal (00711146, 00711147) (EN-MF) Coin Tip Snare (00711110, 00711415, 00711416) (EN-MF) Lariat snare (00711096, 00711097, 00711119) (EN-MF) Endoscope Transport Tote BioShield irrigator (0071113, 00711137) (EN-MF) BioShield Irrigator - extension tubing (00711134) (EN-CFE) BioShield Biopsy Valve (00711124-00711129, 00711135, 00711136) (EN-MF) Bioshield - irrigating adaptor (00711131) (EN-MF) 16 Fr CryoDecompression Tube (CDT) 5 Pack (2000181) (EN-SD) Aire PV Passive Venting Catheter (CO8407030501) (EN-SD) Active Venting Spray Kit, 16 Fr CDT (2000516) (EN-SD) truFreeze System (EN-SD) Active Venting Spray Kit, 20 Fr CDT (2000177) (EN-SD) truFreeze Console (CC301) (EN-SD) 20 Fr CDT 5 Pack (ACCCC3CDT05) (EN-SD) Rapid AV Catheter 5 Pack (2000184) (EN-SD) Torrent irrigation pump (00711569, 00711579) (EN-CFE) Reveal Distal Attachment Cap SmartBand SafeGrip Multi-Band Ligation Kit (EN-MF, IE-SD) SmartBand Ligation Kit (EN-MF, IE-SD) SmartBand SafeGrip Multi-Band Ligation Pack (EN-MF, IE-SD) SmartBand Ligation Pack (EN-MF, IE-SD) Genii ArC Smart probe (EN-CFE) ArC SMART probe (G1140001, G1140002, G1140003) (EN-SD) Oracle EUS Balloon (00711891) (EN-CFE) Short Throw - snare - enteroscope (00711101) (EN-MF) Short Throw - snare - mini-oval (00711018) (EN-MF) Rotator - snare - oval (00711020) (EN-MF) Traxtion hexagonal snare (00711113) (EN-MF) Short Throw - snare - oval (00711019) (EN-MF) Rotator - snare - mini-oval (00711121) (EN-MF) BioGuard Air/Water and Suction valves (00711780) (EN-CFE) Padlock Clip Defect Closure System (C910001) (EN-MF) Padlock Clip Pro-Select Defect Closure System (C913131) (EN-MF) Biopsy Port Valve gi4000 Introduction Kit (00713100) (EN-MF) Suction Polyp Trap (710202) (EN-MF) eTrap Poly Trap (00711099) (EN-MF) InStream Poly Trap (00711098) (EN-MF) Baleen Polyp Trap (NBPT520) (EN-MF) Quick Catch In-Line Suction Poly Trap (710201) (EN-MF) BioShield Biopsy Valve EUS- Linear (00711902, 00711903) (EN-MF) Infinity ERCP sampling device (00711652, 00711653) (EN-MF) Aire PV Passive Venting Catheter (CO8407030501) (EN-SD) Rapid AV Catheter 5 Pack (2000184) (EN-SD) truFreeze Console (CC301) (EN-SD) 20 Fr CDT 5 Pack (ACCCC3CDT05) (EN-SD) Active Venting Spray Kit, 16 Fr CDT (2000516) (EN-SD) truFreeze System (EN-SD) Active Venting Spray Kit, 20 Fr CDT (2000177) (EN-SD) 16 Fr CryoDecompression Tube (CDT) 5 Pack (2000181) (EN-SD) Endoscopic Marker (00711836) (EN-RR) Exacto Mundo cold snare (00711114, 00711078, 00711079) (EN-MF) Exacto cold snare (00711115, 00711094, 00711095) (EN-MF) Polypectomy Snare (EN-CFE) Aire PV Passive Venting Catheter (CO8407030501) (EN-SD) Rapid AV Catheter 5 Pack (2000184) (EN-SD) 16 Fr CDT 5 Pack (2000181) (EN-SD) truFreeze Console (CC301) (EN-SD) Active Venting Spray Kit, 16 Fr CDT (2000516) (EN-SD) 20 Fr CDT 5 Pack (ACCCC3CDT05) (EN-SD) Active Venting Spray Kit, 20 Fr CDT (2000177) (EN-SD) Reliance Endoscope Transport Bin (RETBIN01) (QB-CFE) Reliance Endoscope Transport Cart (RETCART01) (QB-CFE) BioGuard air/water cleaning adapter - Olympus (EN-CFE) UroSeal adjustable endoscopic valve (00913410) (EN-CFE) BioShield Irrigator - extension tubing (00711134) (EN-CFE) Bioshield - irrigating adaptor (00711131) (EN-MF) BioShield Biopsy Valve (00711124-00711129, 00711135, 00711136) (EN-MF) BioShield irrigator (0071113, 00711137) (EN-MF) Lithotomy Legholders - Adult (Pair) (MG-MF) Split Leg Positioner (MG-RR) Shoulder Table (MG-MF) Transducer Support Holder (MG-MF) Table Extenders with/without Pads (MG-MF) Surgical Tabletop Mushroom Cap Conversion Kit (MG-MF) MIO Medical Device Organizer (EN-SD) Arm Supports (MG-RR, MF) Table Side Rails (MG-MF) Ether Screen (MG-MF) Shoulder Table and Accessory Package (MG-RR, MF) ARCH Orthopedic Leg Positioner (MG-RR) CMAX X-ray Table Side Rails (MG-SD, LC-FE, PM-CM) Tibia Counter Traction Assembly (MG-MF) Padlock Clip EFTR Kit (00713229) (EN-MF) VERIFY RESI-TEST Endo Cleaning Indicator (LCC101) (PC-MF) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-MF) VERIFY RESI-TEST Swab Cleaning Indicator (LCC100) (PC-MF) Revital-Ox Single-Ended Channel Brush (2D75QV) (EN-MF) Instrument Cleaning Brushes, Other (HP-RR) Revital-Ox Valve/Control Brush (2D78QV) (EN-MF) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-MF) Cleaning brush - channel (EN-MF) Cleaning brush - channel - maxi (EN-MF) Double Header - channel and control head combo (EN-MF) Revital-Ox Dual-Ended Pull Through Channel Brush (2D76QH) (EN-MF) Cleaning brush - control head (EN-MF) Revital-Ox All-In-One Channel and Valve/Control Brush (2D77QH) (EN-MF) Small Wonder - cleaning brush (EN-MF) Cleaning brush - channel - enteroscope (EN-MF) Gemini - double ended - channel (EN-MF) DuoSwift Cleaning Brush (EN-MF) Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-MF) Wooly Brush - channel (EN-MF) Small Wonder - Double Ended - cleaning brush (EN-MF) Instrument Cleaning Brushes (S-M) (HP-RR) Pipe Cleaners (LC-FE) Inline Tubing Set For Use With Olympus 140, 160, 180, & 190 Series Endoscopes (710424) (EN-CFE) Inline Tubing Set For Use With Pentax Endoscopes (710425) (EN-CFE) Inline tubing Set For Use With Fujifilm Endoscopes (710426) (EN-CFE) Raptor grasping device - mini (00711178) (EN-MF) Raptor grasping device (00711177) (EN-MF) Biopsy forceps - hot - enteroscope (00711295) (EN-CFE) Biopsy forceps - hot (00711211) (EN-CFE) BioVac - direct suction device (00711511, 00711512, 00711513) (EN-MF) Torrent Irrigation Scope Connector (00711570) (EN-CFE) Torrent Irrigation Tubing (00711560) (EN-MF) Check valve, normally closed Reusable Monopolar Active Cord (00711005) (EN-RR, CFE) DEFENDO Olympus EUS Air Water Suction Valve - Radial Biopsy Valve (0711904) (EN-MF) Via procedure kit (EN-SD) BioGuard valves (3-pc) & air/water cleaning adapter kit (00711786) (EN-CFE) BioGuard valves & air/water cleaning adapter kit (00711785) (EN-CFE) BioGuard valves (4-pc) & air/water cleaning adapter kit (00711787) (EN-CFE) DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve (0711901) (EN-MF) TouchSoft Coagulator (G1120040) (EN-CFE, RR) Bite Block-adult-Velcro strap (00712803) (EN-MF) EZ Guard pediatric mouthpiece with foam and Velcro strap (710106) (EN-CFE) Bite Block-pediatric-latex free strap (00712808) (EN-MF) EZ Guard adult mouthpiece with foam, without strap (710101) (EN-MF) Bite Block-maxi-woven strap (00712812) (EN-MF) EZ Guard adult mouthpiece with foam and velcro strap (710103) (EN-MF) Bite Block-maxi-latex free strap (00712804) (EN-MF) Vasto bite block (00712810) (EN-MF) Bite Block-intermediate-latex free strap (00712809) (EN-MF) Bite Block-maxi-no strap (00712805) (EN-MF) Bite Block-adult-latex free strap (00712801) (EN-MF) Bite Block-adult-no strap (00712802) (EN-MF) Respa O2 delivery bite block (00712811) (EN-MF) Bite Block-maxi-Velcro strap (00712806) (EN-MF) DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve (0711901) (EN-MF) Defendo Air Water Suction Valve (00711900) (EN-SD) Take-out Transport Pad (EN-RR) Histolock Resection Device (00711117, 00711871) (EN-MF) Ultramatrix EUS Balloon-Olympus Linear (USBOL) (EN-SD, CFE) Ultramatrix EUS Balloon-Olympus/Pentax Radial (USBOR) (EN-SD, CFE) Bipolar Hemostatic Probe (EN-CFE) Padlock Clip Defect Closure System (EN-CFE) Padlock Clip Pro-Select Defect Closure System (EN-CFE) CO2EFFICIENT ENDOSCOPIC INSUFFLATOR (710302) (EN-SD) Two Tank Shuttle Valve System (710602) (EN-SD) BioShield Irrigator (00711133, 00711137) (EN-MF) BioShield Irrigator - extension tubing (00711134) (EN-CFE) Bioshield - irrigating adaptor (00711131) (EN-MF) BioShield Biopsy Valve (00711124-00711129, 00711135, 00711136) (EN-MF) Moray micro forceps (00711889) (EN-MF) Assurance Clip (00711881, 00711882, 00711883, 00711884) (EN-RR) Genii TouchSoft Coagulator monopolar probe (G1120040) (EN-CFE) Genii ArConnect argon probe connector (G1140004, G1140005, G1140006) (EN-CFE) Genii GI 4000 (G1110001, G1110022) (EN-CFE) Genii Active Cord (G1112006) (EN-CFE) Genii Argon Gas Canister (G1120010, G11200101, G11200104) (EN-CFE) Genii GoCart (G1112003) (EN-CFE) HLT Pads (MG-RR) Beach Chair Pads (MG-MF) Perineal Cutout Filler Piece (MG-MF) Surgical Table Pads (MG-MF, RR) Cmax Xray Mattress (MG-RR) Stretcher Pads (MG-MF) 5085 Harmony Table Pads (MG-RR) Armboard Pads (MG-MF) Birkova Table Pads (MG-MF) Elite Pads (MG-RR) Table Pad Accessory Packages (MG-MF) TLT Pads (MG-RR) Arm Hand Table Pads (MG-MF) Aquagel Pads (MG-RR) Kyra Medical Surgical Table Arm and Leg Pads (MG-CM) BOOST Head Positioner (EN-SD) Table Pads for CMAX XRAY NA Surgical Table (MG-RR) Oasis Pads (MG-RR) Histoguide wire-guided forceps (00711660) (EN-MF) Raptor disposable grasping device- 360 (00711179) (EN-RR) Centra Biopsy Forceps (00711245, 00711247, 00711249, 00711250) (EN-RR) Disposable Biopsy Forceps (EN-CFE) Raptor grasping device (00711177) (EN-MF) Raptor grasping device - mini (00711178) (EN-MF) LUMIFLEX Balloon Inflator Roth Net retriever select (00711169, 00711170, 00711194) (EN-MF) Roth Net retriever - mini polyp (00711158, 00711159) (EN-MF) Roth Net retriever - 360 Non-sterile (00711197) (EN-MF) Roth Net - foreign body enteroscope (00711152) (EN-MF) Roth Net - polyp retrieval (00711150, 00711151) (EN-MF) Roth Net - foreign body maxi (00711059, 00711165) (EN-MF) Roth Net retriever - 360 Sterile (00711198) (EN-MF) Roth Net Platinum - universal (00715050, 00715060) (EN-MF) Roth Net - foreign body standard (00711050, 00711052, 00711053, 00711162) (EN-MF) Roth Net - foreign body mini (00711168, 00711057) (EN-MF) Roth Net Platinum - polyp (00715150, 00715160) (EN-MF) Roth Net Platinum - food bolus (00711155) (EN-MF) Ascendo Submucosal Lifting agent (00712934) (EN-RR) BioGuard Air/Water and Suction valves (00711780) (EN-CFE) UroSeal adjustable endoscopic valve (00913410) (EN-CFE) AquaShield System-Pentax (00711550) (EN-CFE) Aquashield System CO2-Fujifilm (00711553) (EN-CFE) Aquashield System CO2 (00711541, 00711543, 00711549) (EN-CFE) AquaShield System CO2-Pentax (00711551) (EN-CFE) Oracle EUS latex balloon-Olympus linear (00711893) (EN-MF) Oracle EUS Balloon (00711891) (EN-CFE) Oracle EUS latex balloon-Olympus radial (00711892) (EN-MF) Padlock Clip EFTR Kit (00713229) (EN-MF) SmartSnare EMR Hexagonal Snare (SS2301) (EN-RR, IE-SD) SmartBand EMR Pack (SBEMRP, SBEMRP12) (EN-CFE, IE-SD) SmartBand EMR Kit (SBEMRK94) (EN-MF, IE-SD) SmartBand EMR Pack (SBEMRP94) (EN-MF, IE-SD) SmartBand EMR Kit (SBEMRK, SBEMRK12) (EN-CFE, IE-SD) iSnare system-Lariat Snare (00711084) (EN-MF) Aquashield System CO2-Fujifilm (00711553) (EN-CFE) AquaShield System-Pentax (00711550) (EN-CFE) AquaShield System CO2-Pentax (00711551) (EN-CFE) Argon gas canister (G1120010, G11200101) (EN-SD) ArConnect argon probe connector (G1140004, G1140005, G1140006, G1120020) (EN-SD) Water Bottle Holder, 1000ml (G1112008) (EN-SD) gi4000 Electrosurgical Generator (G1110001, G1110022) (EN-SD) GoCart (G1112003) (EN-SD) Articulator injection needle (00711804, 00711807, 00711810) (EN-MF) Articulator injection needle - enteroscope (00711808) (EN-MF) Articulator injection needle (00711803) (EN-CFE) Carr-Locke injection needle (00711811-00711814, 00711822-00711824) (EN-MF) Irrigation Kit Standard (00711554, 00711557) (EN-MF) Irrigation Kit CO2 Long (00711556, 00711559) (EN-MF) Irrigation Kit CO2 Short (00711555, 00711558) (EN-MF) BioGuard air/water & suction valves-Olympus (4 pc kit) (00711784) (EN-CFE) BioGuard air/water & suction valves-Olympus (3 pc kit) (00711783) EN-CFE) Ascendo Submucosal Lifting agent 10mL (00712935) (EN-RR) Roth Net retriever select (00711169, 00711170, 00711194) (EN-MF) Roth Net Platinum - polyp (00715150, 00715160) (EN-MF) Roth Net - foreign body maxi (00711059, 00711165) (EN-MF) Roth Net - polyp retrieval (00711150, 00711151) (EN-MF) Roth Net - foreign body mini (00711168, 00711057) (EN-MF) Roth Net retriever - mini polyp (00711158, 00711159) (EN-MF) Roth Net Platinum - universal (00715050, 00715060) (EN-MF) Roth Net - foreign body enteroscope (00711152) (EN-MF) Roth Net - foreign body standard (00711050, 00711052, 00711053, 00711162) (EN-MF) Roth Net Platinum - food bolus (00711155) (EN-MF)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2020-10-29
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-05-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-10-29
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2024-04-25
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2021-09-09
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2021-09-09
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-10-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2024-01-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-10-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-10-29
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-01-11
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2021-01-11
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2020-10-29
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-04-25
NWI	Electrosurgical Electrode Kit	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-10-29
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2021-03-11
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2022-12-07
NBG	Marker, Colon	Gastroenterology, Urology	Class 2	876.1500	2021-09-26
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2020-10-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2022-08-31
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-10-09
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-10-29
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2024-09-18
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-09-18
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2024-09-18
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2024-09-18
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-10-09
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2020-10-29
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-04-25
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-04-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-10-29
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2020-10-29
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-10-15
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-10-15
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-10-09
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-10-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2020-10-29
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2023-10-22
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-10-22
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2020-10-29
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-11-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-10-29
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2020-10-29
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2025-07-31
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2023-03-23
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2021-01-30
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-10-29
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-05-27
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2025-05-27
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2025-05-27
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2025-05-27
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2024-06-02
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-10-29
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2020-10-29
PRT	Gastric Irrigation And Aspiration Kit	Gastroenterology, Urology	Class 2	876.5980	2020-10-29
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-10-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

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
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
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0006-2013	US Endoscopy Group Inc	2	Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
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

Similar Registrations

Registration Number	Establishment Name	Location
3033841914	TRANSMED (CHINA) CO., LTD.	Nanjing Jiangsu, CN
3044854047	TAURUS ENDOSCOPY, SAS	Strasbourg Grand Est, FR
3004837686	Micro-Tech (Nanjing) Co., Ltd.	NAN JING Jiangsu, CN
3010188783	JAPAN GAS COMPANY LIMITED	YOKOHAMA Kanagawa, JP
3010432890	Sterigenics Costa Rica S.R.L.	El Coyol Alajuela, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528319. Last updated year: 2026. Please use registration number 1528319 when referencing this establishment in official correspondence.