Panels › Gastroenterology, Urology › Product code OCX · Class 2
Endoscopic Irrigation/Suction System
Regulation 876.1500
0510(k)s in 12 months (93 all time)
2recalls in 12 months (18 all time)
18recalls that name a 510(k)
Top companies in OCX
| Company | 510(k)s | Recalls |
|---|---|---|
| Ga Health Company Limited | 6 | 11 |
| Erbe USA, Inc. | 6 | 0 |
| Byrne Medical, Inc. | 5 | 0 |
| Hobbs Medical, Inc. | 3 | 2 |
| Endochoice, Inc. | 4 | 0 |
| United States Endoscopy Group, Inc. | 4 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 3 | 0 |
| Olympus Medical Systems Corporation | 3 | 0 |
| Smartdata Suzhou Co., Ltd. | 3 | 0 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2014 | K131426 | MEDLINE BIOPSY VALVE Medline Industries, Inc. | OCX |
| Dec 20, 2013 | K132776 | SEAL BIOPSY VALVE - REUSABLE Endochoice, Inc. | OCX |
| May 17, 2013 | K122417 | SCOPEVALET DISPOSABLE BIOPSY VALVE The Ruhof Corp. | OCX |
| May 16, 2013 | K130909 | GATEWAY ADVANAGE Y-ADAPTER Boston Scientific Corp | OCX |
| Dec 10, 2012 | K122740 | JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN Jetprep, Ltd. | OCX |
| Jun 29, 2012 | K112318 | CLEARPATH 24 Promedic, Inc. | OCX |
| Apr 27, 2012 | K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP Byrne Medical, Inc. | OCX |
| Apr 4, 2012 | K111274 | JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 Jetprep, Ltd. | OCX |
| Jul 28, 2011 | K111821 | BIOPSY VALVE Endochoice, Inc. | OCX |
| Dec 30, 2010 | K103239 | IRRIGATION SYSTEM United States Endoscopy Group, Inc. | OCX |
| Dec 23, 2010 | K103235 | ERBEFLO 2 DISPOSABLE TUBING SYSTEM Erbe USA, Inc. | OCX |
| Nov 19, 2010 | K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID Byrne Medical, Inc. | OCX |
| Nov 5, 2009 | K092461 | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 United States Endoscopy Group, Inc. | OCX |
| Apr 19, 2006 | K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 Byrne Medical, Inc. | OCX |
| Apr 28, 2004 | K031457 | ENDOMAT LC PUMP, MODEL 20 3303 20 KARL STORZ Endoscopy-America, Inc. | OCX |
| Dec 23, 2003 | K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 Byrne Medical, Inc. | OCX |
| Jun 24, 2003 | K031773 | ENDO GATOR SYSTEM Byrne Medical, Inc. | OCX |
| Jun 9, 2003 | K030765 | HOBBS MISTIFIER SPRAY CATHETER Hobbs Medical, Inc. | OCX |
| Aug 15, 2002 | K021776 | KSEA QUADRO SWITCH Karl Storz Endoscopy | OCX |
| May 24, 2002 | K020614 | IRRIGATING CANNULA Ca Guard, Ltd. | OCX |
| Jan 6, 2000 | K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 Northgate Technologies, Inc. | OCX |
| Sep 1, 1999 | K992535 | ENDIUS SUCTION/IRRIGATION INSTRUMENT Endius, Inc. | OCX |
| May 23, 1997 | K971125 | ENDO SMARTCAP (100501) Endo Smart Cap Co. | OCX |
| Apr 22, 1997 | K970764 | COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES Comeg Endoscopy | OCX |
| Dec 23, 1996 | K964196 | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) Northgate Technologies, Inc. | OCX |
| Oct 13, 1995 | K953655 | J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS Johnson & Johnson Medical, Inc. | OCX |
| Feb 28, 1995 | K942918 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER Tri-Med Specialties, Inc. | OCX |
| Jan 11, 1994 | K934170 | ENDOMEDIX Y-ADAPTER Endomedix | OCX |
| Sep 28, 1993 | K931201 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER Tri-Med Specialties, Inc. | OCX |
| Apr 9, 1991 | K905102 | BARD(R) SYRINGE ASSIST IRRIGATION C.R. Bard, Inc. | OCX |
| Sep 24, 1990 | K903834 | N. M. BEALE COMPANY VU-THRU WATER BOTTLE N.M. Beale Co., Inc. | OCX |
| Jun 22, 1989 | K892426 | NO. 86500 - ENDOSCOPIC JET WASHER Superior Healthcare Group, Inc. | OCX |
| Jun 2, 1989 | K891339 | IRRI-FLO IRRIGATION DELIVERY SYSTEM Surgitek | OCX |
| Oct 25, 1988 | K883173 | MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION KARL STORZ Endoscopy-America, Inc. | OCX |
| Mar 29, 1988 | K875264 | WASHING CATHETER Endovations | OCX |
| Aug 11, 1986 | K862058 | RAPID ENDOSCOPIC LAVAGE SYSTEM Endovations | OCX |
| Jan 3, 1985 | K844550 | HOBBS MEDICAL/JAYCO ASPIRATION CATHETER Hobbs Medical, Inc. | OCX |
| Jan 2, 1985 | K844691 | ENDOSCOPIC ASPIRATION CATHETER SET Jayco Pharmaceuticals | OCX |
| Nov 14, 1983 | K833331 | ASPIRATION & IRRIGATION CATHETER Microvasive | OCX |
| Jul 18, 1983 | K832009 | MODEL #27224P CONTINUOUS FLOW PUMP KARL STORZ Endoscopy-America, Inc. | OCX |
| Jul 20, 1982 | K822061 | LAVAGING CATHETERS American Endoscopy, Inc. | OCX |
| Apr 7, 1981 | K810506 | PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT Propper Mfg. Co., Inc. | OCX |
| Aug 30, 1976 | K760451 | AIR WATER SOURCE (ACMI MODEL 710) American Cystocope Makers, Inc. | OCX |
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