Panels › Gastroenterology, Urology › Product code ODC · Class 2
Endoscope Channel Accessory
Regulation 876.1500
1510(k)s in 12 months (72 all time)
3recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in ODC
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 7 | 0 |
| Boston Scientific | 3 | 1 |
| Byrne Medical Incorporated | 4 | 0 |
| Ga Health Company Limited | 4 | 0 |
| Medivators (A Subsidiary of Steris Corporation) | 3 | 0 |
| Smart Medical Systems , Ltd. | 3 | 0 |
| United States Endoscopy Group, Inc. | 3 | 0 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 3 | 0 |
| Changzhou Endoclean Medical Device Co., Ltd. | 2 | 0 |
| Cook Incorporated | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2012 | K112698 | CONCENTRIC BALLOON GOOGLE United States Endoscopy Group, Inc. | ODC |
| Feb 6, 2012 | K112106 | NAVIAID ICVI-F,S,B,R DEVICE Smart Medical Systems , Ltd., IL | ODC |
| Oct 28, 2011 | K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM Apollo Endosurgery, Inc. | ODC |
| Aug 9, 2011 | K111760 | NAVIAID(TM) BGC DEVICE Smart Medical Systems , Ltd., IL | ODC |
| Jun 17, 2011 | K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE Smart Medical Systems , Ltd., IL | ODC |
| Jun 10, 2011 | K110088 | DEFENDO Y-OPSY IRRIGATOR Byrne Medical Incorporated | ODC |
| Nov 8, 2010 | K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 Byrne Medical, Inc. | ODC |
| Nov 4, 2010 | K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 Byrne Medical, Inc. | ODC |
| May 17, 2010 | K101094 | CLEARJET Easyglide , Ltd. | ODC |
| Feb 16, 2010 | K093329 | SCOPE INTRODUCER MODEL 7400 N.M. Beale Co., Inc. | ODC |
| Jul 2, 2009 | K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) Byrne Medical, Inc. | ODC |
| May 6, 2008 | K080764 | SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 Max Endoscopy, Inc. | ODC |
| Mar 10, 2008 | K073484 | ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 Ethicon Endo-Surgery, Inc. | ODC |
| Mar 5, 2008 | K073507 | ANCHORAGE ACCESS KIT Epitek, Inc. | ODC |
| Mar 24, 2003 | K024301 | LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT Lsi Solutions | ODC |
| Mar 27, 2001 | K010610 | RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 Boston Scientific Corp | ODC |
| Feb 19, 1997 | K970110 | BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) Bard Medical Div. | ODC |
| Mar 18, 1992 | K920030 | SURESEAL ENDOSCOPIC VALVE Applied Urology, Inc. | ODC |
| Feb 18, 1992 | K915719 | ANGEION ENDOSCOPIC VALVE SEAL Angeion Corp. | ODC |
| Apr 17, 1989 | K884097 | MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES Circon Acmi | ODC |
| Sep 11, 1986 | K862107 | PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR Penn Medical Devices, Inc. | ODC |
| May 8, 1980 | K800962 | M.R. ASSOC. WASHING TUBE/MEASURING TUBE Mr Associates, Inc. | ODC |
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