FDA.reportPublic FDA data

UNITED STATES ENDOSCOPY GROUP, INC.

Matched from indexed company URL: UNITED STATES ENDOSCOPY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15283191000122656UNITED STATES ENDOSCOPY GROUP, INC.1N2026-01-015976 Heisley Rd Mentor OH US 44060
15283191000122656UNITED STATES ENDOSCOPY GROUP, INC.1N2020-04-255976 Heisley Rd Mentor OH US 44060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2021531023919839K992178BALLOON FOR ULTRASONIC ENDOSCOPESITX2000-05-12
2021531037089134K971842COAXIAL NEEDLEFCG1997-06-20
2816631603132955K971842COAXIAL NEEDLEFCG1997-06-20
2021531637331145K971125ENDO SMARTCAP (100501)OCX1997-05-23
2021531218857410K962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEFGO1996-10-04
2816631972265114K962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEFGO1996-10-04
2021531391255775K955248U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KITKNT1996-05-21
2021531456874529K954879PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)KNT1996-03-29
2816631424786589K951104ENDOBOOTOCU1995-04-06
2021531771420998K951104ENDOBOOTOCU1995-04-06
2021531809810324K925361BIOPSY FORCEPS, ELECTRICKGE1993-03-29
2816631987391451K925361BIOPSY FORCEPS, ELECTRICKGE1993-03-29
2021531087503125K924106BIOPSY FORCEPSKNW1992-11-24
2816631972998649K924106BIOPSY FORCEPSKNW1992-11-24
2021531002689206K924105SNARE FLEXIBLEFDI1992-11-24
2816631315575682K924105SNARE FLEXIBLEFDI1992-11-24
2021531026155702K924104CYTOLOGY BRUSHFDX1992-11-24
2816631957583790K924104CYTOLOGY BRUSHFDX1992-11-24
2021531320895691K915360LAPAROSCOPIC SNARE POUCHGCJ1992-01-27
2021531487130277K911487LAPAROSCOPIC CHOLANGIOCATHGCA1991-08-14
2021531765375235K882048MEDITRON ENDOLAV MODEL EL-100KNS1988-10-31
2816631768624008K882048MEDITRON ENDOLAV MODEL EL-100KNS1988-10-31
2816631592045325K250842PADLOCK CLIP EFTR Kit (00713229)PKL2025-04-18
2816631569099039K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC2024-10-11
2816631850078922K241888Single-use Balloon Dilatation CatheterFGE2024-12-20
2816631153911514K241591Blue EyePLL2024-07-03
2816631401022612K240274PADLOCK CLIP EFTR Kit (00713229)PKL2024-09-17
2816631100316684K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC2024-02-09
2816631702999148K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)ODC2023-10-20
2816631748047282K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)FBK2024-03-08
2816631284940712K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterODC2023-12-21
2816631832483470K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingOCX2023-08-01
2816631815780635K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184GEH2022-12-02
2816631546074787K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184GEH2022-08-18
2816631670502007K220434Blue Eye (TS-905)PLL2022-08-12
2816631407648329K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)FDI2021-10-07
2816631008436251K212668Sclerotherapy NeedleFBK2022-02-23
2816631480018645K211787HemoclipPKL2022-03-03
2816632001320929K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating AdaptorODC2021-09-03
2816631623636461K203630BioGuard Air/Water and Suction ValvesODC2021-01-08
2816631112939101K202583BioShield biopsy valve EUS - LinearODD2020-11-06
2816632012467329K202104BioGuard EUS Air/Water and Suction ValvesODC2021-01-14
2816631620010312K201183Vortex Radial Spray CatheterGEH2020-12-07
2816631151910601K200745Lariat, Hot/Cold SnareFDI2020-04-21
2816631635428015K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorODC2020-06-18
2816631149000532K192722Padlock Clip defect closure system, Padlock Pro-Select defect closure devicePKL2019-10-24
2816631165181450K192518Reusable Monopolar Active CordGEI2019-10-25
2021531223785171K192518Reusable Monopolar Active CordGEI2019-10-25
2816631816999963K192265gi-4000 Electrosurgical GeneratorGEI2020-05-21
2816631408215220K192059Bio Guard Air/Water & Suction ValvesODC2019-09-17
2021532036024858K192059Bio Guard Air/Water & Suction ValvesODC2019-09-17
2021531102004029K191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileOCU2020-01-27
2816631910254462K191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileOCU2020-01-27
2816631859514875K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ2019-08-01
2021532045075340K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ2019-08-01
2816631743289442K191366Vacutore Air/Water Bottle TubingOCX2019-09-06
2021531184228911K182909Roth Net Retriever Product LineFDI2018-11-21
2816631583214832K182909Roth Net Retriever Product LineFDI2018-11-21
2021531345582039K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ2018-09-21
2816631373426677K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ2018-09-21
2021532029090670K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB2018-12-14
2816631182117687K181509Endorate Valve SetsOCX2018-07-06
2021531080354617K180731Ultramatrix EUS BalloonODG2018-04-19
2816631977266991K180731Ultramatrix EUS BalloonODG2018-04-19
2816631695924985K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure devicePKL2018-04-12
2021531939071259K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure devicePKL2018-04-12
2816631288168915K172805gi-4000 Electrosurgical GeneratorGEI2017-10-23
2021532058375392K172805gi-4000 Electrosurgical GeneratorGEI2017-10-23
2816631275892336K172729Polypectomy SnareFDI2018-05-21
2816631547044693K172727HemoclipPKL2018-04-16
2021531992505213K172727HemoclipPKL2018-04-16
2021531308738796K172041truFreeze SystemGEH2017-07-27
2816631384512632K171626truFreeze SystemGEH2017-08-30
2021531561824470K171626truFreeze SystemGEH2017-08-30
2021531406957608K171522truFreeze Rapid AV Spray KitGEH2017-07-14
2816631099346662K163495AdvanCE capsule endoscope delivery deviceNEZ2017-03-10
2021531807432913K163495AdvanCE capsule endoscope delivery deviceNEZ2017-03-10
2816631194053068K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon LinearFDF2017-01-06
2021531718988937K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon LinearFDF2017-01-06
2021531498187741K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONFEQ2017-01-04
2816631672834236K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONFEQ2017-01-04
2021531748893980K163244truFreeze SystemGEH2017-05-24
2021531232245933K162695truFreeze SystemGEH2016-10-25
2021531070523374K161557truFreeze SystemGEH2016-07-26
2021531267893958K160273truFreeze SystemGEH2016-03-25
2021531344896136K152668truFreeze SystemGEH2015-10-14
2021531516404011K152035iSnare system-LariatFBK2015-10-15
2816631531044924K152035iSnare system-LariatFBK2015-10-15
2816631523576627K151889Infinity ERCP Sampling DeviceFDX2015-07-30
2021531647056152K151889Infinity ERCP Sampling DeviceFDX2015-07-30
2816631313029261K151197Lariat snareFDI2015-07-06
2021531872834164K151197Lariat snareFDI2015-07-06
2021531239930644K150920truFreeze SystemGEH2015-06-17
2021532027320091K143625truFreeze SystemGEH2015-01-15
2816631414451220K140763MONOFILAMENT POLYPECTOMY SNAREFDI2014-04-24
2021531661868681K140763MONOFILAMENT POLYPECTOMY SNAREFDI2014-04-24
2816631285165395K140405TORRENT IRRIGATION SYSTEMOCX2014-03-12
2021531825008844K140405TORRENT IRRIGATION SYSTEMOCX2014-03-12
2021531355543525K140315US ENDOSCOPY DISTAL ATTACHMENT CAPOCX2014-04-04
2816632061022367K140315US ENDOSCOPY DISTAL ATTACHMENT CAPOCX2014-04-04
2021531736531152K133258TRUFREEZE SYSTEMGEH2014-06-19
2021531208110469K130983GENII ARC SMART ARGON PROBEGEI2013-09-26
2816631209194241K130983GENII ARC SMART ARGON PROBEGEI2013-09-26
2021531047144229K123047BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETFCX2013-08-06
2816631557395228K123047BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETFCX2013-08-06
2021531041818439K122462ROTH NET RETRIEVERFDI2012-09-11
2816631581185778K122462ROTH NET RETRIEVERFDI2012-09-11
2021531175434770K120814PADLOCK CLIP-12PKL2012-09-06
2816631710528665K120814PADLOCK CLIP-12PKL2012-09-06
2816631620846636K120084ENDOSCOPIC RETRIEVAL DEVICEOCZ2012-05-30
2021531760371196K120084ENDOSCOPIC RETRIEVAL DEVICEOCZ2012-05-30
2816631002897698K113265GENII GI 4000 ELECTROSUGICAL GENERATORGEI2012-03-22
2021531945469341K113265GENII GI 4000 ELECTROSUGICAL GENERATORGEI2012-03-22
2021531539966621K113021TRUFREEZE SYSTEM, TRUFREEZE SPRAY KITGEH2012-02-07
2021531116892614K111648BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORFCX2011-11-03
2816631460504093K111648BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORFCX2011-11-03
2021531319800022K111028EUS BALLOONFDF2011-11-01
2816631394310233K111028EUS BALLOONFDF2011-11-01
2816631555671255K103239IRRIGATION SYSTEMOCX2010-12-30
2021531937933644K103239IRRIGATION SYSTEMOCX2010-12-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH202022-12-02
FDI152021-10-07
OCX112023-08-01
PKL102025-04-18
ODC102024-10-11
GEI92020-05-21
FEQ82019-08-01
FCX62013-08-06
FDF52017-01-06
KNS52010-09-07
FBK42024-03-08
OCU42020-01-27
FDX42015-07-30
FED42010-04-12
ODD32020-11-06
NEZ32017-03-10
PLL22024-07-03
ODG22018-04-19
OCZ22012-05-30
FCG21997-06-20
FGO21996-10-04
KNT21996-05-21
KGE21993-03-29
KNW21992-11-24
FGE12024-12-20
FEB12018-12-14
KMJ12004-05-07
ITX12000-05-12
GCJ11992-01-27
GCA11991-08-14

PMN#

EUS BALLOON

2011-11-01

UNITED STATES ENDOSCOPY GROUP, INC.

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