Company ยท US
United States Endoscopy Group, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2020. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 11 |
| FDI | Snare, Flexible | 10 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 6 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| FCK | Instrument, Biopsy, Suction | 4 |
| FDX | Endoscopic Cytology Brush | 4 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 4 |
| OCX | Endoscopic Irrigation/Suction System | 4 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 |
| ODC | Endoscope Channel Accessory | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 |
| FCG | Biopsy Needle | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 |
| FEB | Accessories, Cleaning, For Endoscope | 2 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 |
| JXL | Block, Bite | 2 |
| KGE | Forceps, Biopsy, Electric | 2 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 2 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2020 | K192265 | gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc. | GEI |
| Apr 21, 2020 | K200745 | Lariat, Hot/Cold Snare United States Endoscopy Group, Inc. | FDI |
| Sep 17, 2019 | K192059 | Bio Guard Air/Water & Suction Valves United States Endoscopy Group, Inc. | ODC |
| Aug 1, 2019 | K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM United States Endoscopy Group, Inc. | FEQ |
| Nov 21, 2018 | K182909 | Roth Net Retriever Product Line United States Endoscopy Group, Inc. | FDI |
| Sep 21, 2018 | K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm United States Endoscopy Group, Inc. | FEQ |
| Jan 5, 2018 | K173650 | AquaShield System CO2- Fujifilm United States Endoscopy Group, Inc. | FEQ |
| Oct 23, 2017 | K172805 | gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc. | GEI |
| Mar 10, 2017 | K163495 | AdvanCE capsule endoscope delivery device United States Endoscopy Group, Inc. | NEZ |
| Jan 6, 2017 | K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS lat United States Endoscopy Group, Inc. | FDF |
| Dec 16, 2015 | K153362 | AquaShield system CO2, AquaShield system-PENTAX United States Endoscopy Group, Inc. | FEQ |
| Oct 15, 2015 | K152035 | iSnare system-Lariat United States Endoscopy Group, Inc. | FBK |
| Aug 25, 2015 | K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve United States Endoscopy Group, Inc. | ODC |
| Jul 30, 2015 | K151889 | Infinity ERCP Sampling Device United States Endoscopy Group, Inc. | FDX |
| Jul 6, 2015 | K151197 | Lariat snare United States Endoscopy Group, Inc. | FDI |
| Apr 4, 2014 | K140315 | US ENDOSCOPY DISTAL ATTACHMENT CAP United States Endoscopy Group, Inc. | OCX |
| Mar 12, 2014 | K140405 | TORRENT IRRIGATION SYSTEM United States Endoscopy Group, Inc. | OCX |
| Feb 26, 2014 | K131598 | ANAL RECTAL OVERTUBE United States Endoscopy Group, Inc. | FED |
| Jan 7, 2014 | K133736 | ENDOSCOPIC SUTURE CUTTER United States Endoscopy Group, Inc. | OCZ |
| Dec 20, 2013 | K133513 | MULTI-STAGE SNARE United States Endoscopy Group, Inc. | FDI |
| Aug 7, 2013 | K130148 | FOREIGN BODY HOOD United States Endoscopy Group, Inc. | FDS |
| Sep 11, 2012 | K122462 | ROTH NET RETRIEVER United States Endoscopy Group, Inc. | FDI |
| May 30, 2012 | K120084 | ENDOSCOPIC RETRIEVAL DEVICE United States Endoscopy Group, Inc. | OCZ |
| May 18, 2012 | K112698 | CONCENTRIC BALLOON GOOGLE United States Endoscopy Group, Inc. | ODC |
| Mar 28, 2012 | K120123 | AQUASHIELD CO2 SYSTEM United States Endoscopy Group, Inc. | FEQ |
| Nov 1, 2011 | K111028 | EUS BALLOON United States Endoscopy Group, Inc. | FDF |
| Jul 27, 2011 | K103694 | TISSUE SAMPLING NEEDLE United States Endoscopy Group, Inc. | FCG |
| May 9, 2011 | K103611 | UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION United States Endoscopy Group, Inc. | FDI |
| Apr 6, 2011 | K103326 | MULTIPLE BIOPSY SYSTEM United States Endoscopy Group, Inc. | FCK |
| Dec 30, 2010 | K103239 | IRRIGATION SYSTEM United States Endoscopy Group, Inc. | OCX |
| Dec 23, 2010 | K103437 | US ENDOSCOPY CYTOLOGY BRUSH United States Endoscopy Group, Inc. | FDX |
| Jul 16, 2010 | K101146 | WATER BOTTLE CAP SYSTEM United States Endoscopy Group, Inc. | FEQ |
| Apr 12, 2010 | K100081 | ENTEROSCOPY OVERTUBE, MODEL 00712140 United States Endoscopy Group, Inc. | FED |
| Nov 5, 2009 | K092461 | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 United States Endoscopy Group, Inc. | OCX |
| Oct 20, 2009 | K092221 | COLONIC SPLINTING OVERTUBE, MODEL 00711145 United States Endoscopy Group, Inc. | FED |
| Mar 19, 2007 | K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 United States Endoscopy Group, Inc. | ODD |
| May 30, 2006 | K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 United States Endoscopy Group, Inc. | FCK |
| Oct 31, 2005 | K051637 | DSNARE, MODEL 00711087 United States Endoscopy Group, Inc. | FCK |
| Jul 8, 2004 | K040961 | INJECTOR NEEDLE/SNARE United States Endoscopy Group, Inc. | FDI |
| Jun 23, 2004 | K040494 | CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 United States Endoscopy Group, Inc. | NEZ |
| Jun 10, 2004 | K040836 | DISPOSABLE OVERTUBE United States Endoscopy Group, Inc. | FED |
| Dec 7, 1999 | K984168 | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE United States Endoscopy Group, Inc. | FCF |
| Sep 18, 1997 | K972505 | RESUABLE HOT BIOPSY FORCEPS United States Endoscopy Group, Inc. | KGE |
| Jun 20, 1997 | K971842 | COAXIAL NEEDLE United States Endoscopy Group, Inc. | FCG |
| May 7, 1997 | K970945 | ANGLED TIP POLYPECTOMY SNARE United States Endoscopy Group, Inc. | KNS |
| Mar 28, 1997 | K963051 | ERCP CANNULA United States Endoscopy Group, Inc. | ODD |
| Mar 25, 1997 | K970356 | IRRIGATION/ASPIRATION POLYPECTOMY United States Endoscopy Group, Inc. | FDI |
| Oct 4, 1996 | K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE United States Endoscopy Group, Inc. | FGO |
| Aug 8, 1996 | K962346 | PAPILLOTOME United States Endoscopy Group, Inc. | KNS |
| Jul 22, 1996 | K961762 | REUSABLE ENDOSCOPIC ACCESSORY HANDLE United States Endoscopy Group, Inc. | KNS |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||