Medical Device Manufacturer · US , Mentor , OH

United States Endoscopy Group, Inc.

94 submissions · 92 cleared · Since 1991
94
Total
92
Cleared
0
Denied

United States Endoscopy Group, Inc. — FDA 510(k) Submissions

United States Endoscopy Group, Inc. has submitted 94 FDA 510(k) premarket notifications since 1991, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscope, General & Plastic Surgery, Snare, Flexible, Pump, Air, Non-manual, For Endoscope, Tubes, Gastrointestinal (and Accessories), Electrosurgical, Cutting & Coagulation & Accessories . Use the specialty filter in the sidebar to narrow results.

94 devices
1–25 of 94
gi-4000 Electrosurgical Generator
K192265 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2020 274d
Lariat, Hot/Cold Snare
K200745 · FDI Snare, Flexible · Gastroenterology & Urology
Apr 2020 29d
Bio Guard Air/Water & Suction Valves
K192059 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Sep 2019 47d
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
K191559 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Aug 2019 49d
Roth Net Retriever Product Line
K182909 · FDI Snare, Flexible · Gastroenterology & Urology
Nov 2018 35d
AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
K182258 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Sep 2018 31d
AquaShield System CO2- Fujifilm
K173650 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Jan 2018 38d
gi-4000 Electrosurgical Generator
K172805 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2017 35d
AdvanCE capsule endoscope delivery device
K163495 · NEZ System, Imaging,... · Gastroenterology & Urology
Mar 2017 87d
Oracle 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 Linear
K163492 · FDF Colonoscope And... · Gastroenterology & Urology
Jan 2017 24d
AquaShield system CO2, AquaShield system-PENTAX
K153362 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Dec 2015 26d
iSnare system-Lariat
K152035 · FBK Endoscopic Injection... · Gastroenterology & Urology
Oct 2015 85d
BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Aug 2015 98d
Infinity ERCP Sampling Device
K151889 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
Jul 2015 20d
Lariat snare
K151197 · FDI Snare, Flexible · Gastroenterology & Urology
Jul 2015 62d
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · OCX Endoscopic... · Gastroenterology & Urology
Apr 2014 53d
TORRENT IRRIGATION SYSTEM
K140405 · OCX Endoscopic... · Gastroenterology & Urology
Mar 2014 22d
ANAL RECTAL OVERTUBE
K131598 · FED Endoscopic Access... · Gastroenterology & Urology
Feb 2014 268d
ENDOSCOPIC SUTURE CUTTER
K133736 · OCZ Endoscopic... · Gastroenterology & Urology
Jan 2014 29d
MULTI-STAGE SNARE
K133513 · FDI Snare, Flexible · Gastroenterology & Urology
Dec 2013 38d
FOREIGN BODY HOOD
K130148 · FDS Gastroscope And... · Gastroenterology & Urology
Aug 2013 197d
ROTH NET RETRIEVER
K122462 · FDI Snare, Flexible · Gastroenterology & Urology
Sep 2012 29d
ENDOSCOPIC RETRIEVAL DEVICE
K120084 · OCZ Endoscopic... · Gastroenterology & Urology
May 2012 140d
CONCENTRIC BALLOON GOOGLE
K112698 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
May 2012 245d
AQUASHIELD CO2 SYSTEM
K120123 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Mar 2012 71d

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