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United States Endoscopy Group, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
94
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K192265gi-4000 Electrosurgical GeneratorMay 21, 2020
K200745Lariat, Hot/Cold SnareApril 21, 2020
K192059Bio Guard Air/Water & Suction ValvesSeptember 17, 2019
K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMAugust 1, 2019
K182909Roth Net Retriever Product LineNovember 21, 2018
K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmSeptember 21, 2018
K173650AquaShield System CO2- FujifilmJanuary 5, 2018
K172805gi-4000 Electrosurgical GeneratorOctober 23, 2017
K163495AdvanCE capsule endoscope delivery deviceMarch 10, 2017
K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus LiJanuary 6, 2017
K153362AquaShield system CO2, AquaShield system-PENTAXDecember 16, 2015
K152035iSnare system-LariatOctober 15, 2015
K151345BioGuard Air/Water Valve, BioGuard Suction ValveAugust 25, 2015
K151889Infinity ERCP Sampling DeviceJuly 30, 2015
K151197Lariat snareJuly 6, 2015
K140315US ENDOSCOPY DISTAL ATTACHMENT CAPApril 4, 2014
K140405TORRENT IRRIGATION SYSTEMMarch 12, 2014
K131598ANAL RECTAL OVERTUBEFebruary 26, 2014
K133736ENDOSCOPIC SUTURE CUTTERJanuary 7, 2014
K133513MULTI-STAGE SNAREDecember 20, 2013