Panels › General, Plastic Surgery › Product code GBZ · Class 1
Catheter, Cholangiography
Regulation 878.4200
0510(k)s in 12 months (24 all time)
3recalls in 12 months (27 all time)
13recalls that name a 510(k)
Top companies in GBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Atrium Medical Corp. | 1 | 24 |
| Applied Medical Resources | 3 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| American Catheter Corp | 0 | 1 |
| Angiomed U.S., Inc. | 1 | 0 |
| Boston Scientific Corp | 1 | 0 |
| Cd Medical, Inc. | 1 | 0 |
| Clarus Medical Systems, Inc. | 1 | 0 |
| Cook Inc. | 0 | 1 |
| Ethicon Endo-Surgery, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 1997 | K973621 | PRE-VIEW CHOLANGIOGRAPHY CLAMP Nashville Surgical Instruments | GBZ |
| Nov 29, 1994 | K944790 | FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Applied Medical Resources | GBZ |
| Aug 5, 1994 | K942450 | ENDOPATH Ethicon Endo-Surgery, Inc. | GBZ |
| Aug 10, 1993 | K932228 | MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER Boston Scientific Corp | GBZ |
| Jul 13, 1993 | K926217 | TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE Terumo Medical Corp. | GBZ |
| Jul 7, 1993 | K926143 | ANGIOLAPCATH CHOLANGIOGRAPHY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | GBZ |
| Jul 7, 1993 | K924212 | STRYKER ENDOSCOPY CHOLANGIOGRAM KIT Stryker Corp. | GBZ |
| Jun 1, 1993 | K925742 | CLARUS CHOLANGIOGRAM CATHETER KIT Clarus Medical Systems, Inc. | GBZ |
| Apr 6, 1993 | K924981 | OPERATIVE CHOLANGIOGRAM CATHETER Taut, Inc. | GBZ |
| Mar 3, 1993 | K924480 | CHOLANGIOGRAPHY CLAMP Applied Medical Resources | GBZ |
| Feb 10, 1993 | K924128 | CHOLANGIOGRAPHY CATHETER Applied Medical Resources | GBZ |
| May 6, 1992 | K921091 | CHOLANGIOLAPCATH(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic | GBZ |
| May 6, 1992 | K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE O.R. Concepts, Inc. | GBZ |
| Nov 21, 1991 | K914015 | CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP Pilling Co. | GBZ |
| Oct 26, 1990 | K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH Lifestream Int'L, Inc. | GBZ |
| Jun 26, 1990 | K901520 | WURTZ CHOLEY CLIP (TM) Cd Medical, Inc. | GBZ |
| Oct 17, 1989 | K895285 | MENTOR DUCTAL CATHETERS Mentor Corp. | GBZ |
| Oct 23, 1987 | K873471 | LMI CHOLANGIOGRAM TRAY Lazarus Medical Innovations, Inc. | GBZ |
| Apr 14, 1987 | K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY North Coast Medi-Tek | GBZ |
| Mar 10, 1986 | K860534 | BILE ENDOPROSTHESIS SET Angiomed U.S., Inc. | GBZ |
| Dec 12, 1983 | K833059 | SUCTION CATHETER TRAYS Intermed, Inc. | GBZ |
| Oct 4, 1983 | K831931 | ATRIUM THORACIC CATHETER Atrium Medical Corp. | GBZ |
| May 2, 1983 | K830711 | TRACHESTOMY & NASAL SUCTIONING KIT #- Intertex Medical | GBZ |
| Jan 30, 1978 | K772288 | CATHETER, CHOLANGIOGRAM, OPERATIVE Gesco Intl., Inc. | GBZ |
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