BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UNITED STATES ENDOSCOPY GROUP, INC.

    Reg #: 1528319 · FEI: 1000122656 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    286
    Establishment Types
    4
    Classifications
    51

    Registration Details

    Registration Name
    UNITED STATES ENDOSCOPY GROUP, INC.
    Registration Number
    1528319
    FEI Number
    1000122656
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5976 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180689

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Hemostatic Metal Clip For The Gi Tract PKL
    Endoscopic Irrigation/Suction System OCX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Endoscope Channel Accessory ODC
    Pump, Air, Non-Manual, For Endoscope FEQ
    Colonoscope And Accessories, Flexible/Rigid FDF
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Snare, Flexible FDI
    Tray, Biopsy, Without Biopsy Instruments FCH
    Unit, Cryosurgical, Accessories GEH
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Ligator, Hemorrhoidal FHN
    Transducer, Ultrasonic, Diagnostic ITX
    Electrosurgical Electrode Kit NWI
    Bottle, Collection, Vacuum KDQ
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Endoscopic Cytology Brush FDX
    Marker, Colon NBG
    Snare, Non-Electrical FGX
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Table And Attachments, Operating-Room BWN
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Accessories, Cleaning Brushes, For Endoscope MNL
    Gastroscope And Accessories, Flexible/Rigid FDS
    Forceps, Biopsy, Electric KGE
    Evacuator, Gastro-Urology KQT
    Endoscope Introducer Kit NWU
    Endoscopic Bite Block MNK
    Container, Specimen, Sterile FMH
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Forceps, Biopsy, Non-Electric FCL
    Surgical Table Cushion LWG
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Syringe, Balloon Inflation, Exempt PTM
    Laparoscope, General & Plastic Surgery GCJ
    Submucosal Injection Agent PLL
    Connector, Ureteral Catheter EYK
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Biopsy Needle FCG
    Gastric Irrigation And Aspiration Kit PRT
    Dislodger, Stone, Flexible FGO
    Cleaner, Ultrasonic, Medical Instrument FLG
    Dilator, Esophageal KNQ
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Endoscopic Storage Cover OCU
    Gastro-Urology Biopsy Kit PRV
    Instrument, Biopsy KNW
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Ligator, Esophageal MND

    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) 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) 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) 16 Fr CDT 5 Pack (2000181) (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) 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 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) 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) 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) 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 latex balloon-Olympus radial (00711892) (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) Argon gas canister (G1120010, G11200101) (EN-SD) ArConnect argon probe connector (G1140004, G1140005, G1140006, G1120020) (EN-SD) Water Bottle Holder, 1000ml (G1112008) (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) FastFlo Injection Needle (00711828-00711831) (EN-RR) Talon Grasping Device (00711175) (EN-MF) Falcon rotatable retrieval basket (00711141) (EN-CFE) STANDARD BASKET FOR ULTRA+ (MD-MF) Prolystica HP Enzymatic Automated Detergent (1C22) (SL-MF, SLDC-RR) Liqui Jet 2 (SL-CFE) Prolystica Ultra Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Valsure Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Neutral Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Enzymatic Presoak and Cleaner (SL-MF, SLDC-RR) RTU Concentrated Z-Sponge RTU Foaming Z-Sponge Distal Duck Kit (MD-CFE) Prolystica HP Neutral Manual Cleaner (1C27) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner (1C24) (SL-MF, SLDC-RR) Prolystica HP Alkaline Automated Detergent (1C20) (SL-MF, SLDC-RR) InnoWave ECO ULTRASONIC CLEANER (5.3 GAL) (MD-MF) Valsure Enzymatic Cleaner (SL-MF, SLDC-RR) STANDARD BASKET FOR ULTRA (MD-MF) Valsure Neutral Detergent (SL-MF, SLDC-RR) InnoWave ECO 2.6 Gallon Standard Mesh Basket (MD-MF) 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE) Multi-Enzymatic Foaming Cleanser RTU InnoWave ULTRA SONIC IRRIGATOR (MD-MF) INSTRUMENT ORGANIZERS FOR PCF (MD-CFE) VERIFY DualAction Ultrasonic Indicator (DUI) (LCC027) Prolystica Ultra Concentrate HP Enzymatic Cleaner (1C16) (SL-MF, SLDC-RR) InnoWave Unity Sonic Irrigator (MD-MF) Renu Klenz (SL-MF, SLDC-RR) Multi-Enzymatic Cleaner (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA (MD-MF) Prolystica HP Alkaline Manual Cleaner (1C26) (SL-MF, SLDC-RR) Prolystica Ultra Concentrate HP Alkaline Detergent (1C17) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner Dye & Fragance (1C23) (SL-MF, SLDC-RR) InnoWave Unity 20 Sonic Irrigator (MD-MF) Klenzyme (SL-CFE) InnoWave ECO ULTRASONIC CLEANER (2.6 GAL) (MD-MF) Post Procedure Enzymatic Cleaning Kit InnoWave ULTRA+ SONIC IRRIGATOR (MD-MF) Prolystica HP Neutral Automated Detergent (1C21) (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA+ (MD-MF) Prolystica Ultra Concentrate HP Neutral Detergent (1C15) (SL-MF, SLDC-RR) InnoWave ECO 5.3 Gallon Standard Mesh Basket (MD-MF) Non-Foaming Multi-Enzymatic Cleanser VERIFY DualAction Ultrasonic Indicator Holder (LCC028) Distal Tip Soakers (MD-CFE) Pre-Klenz Enzymatic Soak Shield Kit 2D66Q5, 2D66J3, 2D66J4, 2D66J6 (SL-MF) AquaShield System (00711540, 00711542, 00711544, 00711545) (EN-CFE) Air/Water Bottle Tubing (EN-CFE) iSnare system - oval snare (00711085, 00711086) (EN-MF) iSnare system - hexagonal snare (00711088, 00711089) (EN-MF) LUMIFLEX 3-Stage Dilatation Balloon Catheter Defendo Air Water Suction Valve (00711900) (EN-MF) ProArmor Endoscope Tip Protector ( 00711623, 00711624) Polyp Pak (00711091) (EN-MF) Hemostasis Clip (EN-CFE) ENDO-BOOT endoscope tip protector (00711621, 00711622) (EN-MF) Vortex Radial Spray Catheter (2000360) (EN-SD) Biopsy Forceps (00711201, 00711202, 00711203, 00711204) (EN-CFE) Biopsy Forceps - enteroscope (00711291) (EN-CFE) Biopsy Forceps - sheathed (00711205) (EN-CFE) Biopsy Forceps - pediatric (00711261, 00711262) (EN-CFE) Endochoice Drive Wire Colonoscope Stiffening Device Enteroscope Stiffening Device Endoscope Stiffening System Carr-Locke Injection Needle Articulator Injection Needle Torrent irrigation scope connector - Pentax (00711571) (EN-CFE) Torrent irrigation tubing (00711560, 00711561, 00711562) (EN-CFE) ADVANCE CAPSULE DELIVERY DEVICE (00711144) (EN-MF) Infinity Cytology Brush Gastrointestinal Guide Wire (EN-CFE)

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198