Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 20
- Latest Decision
- 1976-10-21
Clearances · page 114 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K760715 | FLEXIBLE CUTTING SCISSORS | V. Mueller O.V. Baxter Healthcare Corp. | KOA | Class I | 1976-10-21 |
| K760069 | BAG, LEG, URINE COLLECTING DEVICE | Pharmaseal Div., Baxter Healthcare Corp. | KNX | Class II | 1976-10-20 |
| K760260 | BAG, DISPOSABLE URINARY LEG | Intermed, Inc. | KNX | Class II | 1976-10-20 |
| K760440 | CATHETER, NATURAL LATEX URETHRAL | Akron Catheter, Inc. | KOD | Class II | 1976-10-20 |
| K760544 | CATHETER, PERITONEAL DIALYSIS | Travenol Laboratories, S.A. | FKO | Class II | 1976-10-20 |
| K760793 | ADAPTER FOR ELLIK EVACUATOR | V. Mueller O.V. Baxter Healthcare Corp. | FFD | Class I | 1976-10-15 |
| K760631 | FILTER SET 1288 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760640 | FILTER SET, PMF 1024 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760639 | FILTER SET, PMF 2028 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760252 | DIALYZER, HF 130 HOLLOW FIBER | Cobe Laboratories, Inc. | FJI | Class II | 1976-10-15 |
| K760626 | FILTER SET PMF 2288 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760735 | BONGORT SPECIAL ODORPROOF DRAIN | Howmedica Corp. | EXB | Class I | 1976-10-15 |
| K760627 | FILTER SET PMF 2168 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760178 | ELECTRODE, CUTTING LOOP | V. Mueller O.V. Baxter Healthcare Corp. | KNS | Class II | 1976-10-15 |
| K760716 | FLEXIBLE FOREIGN BODY FORCEPS | V. Mueller O.V. Baxter Healthcare Corp. | KOA | Class I | 1976-10-15 |
| K760630 | FILTER SET PMF 200 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760637 | FILTER SET, PMF 1448 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760628 | FILTER SET PMF 2448 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760633 | FILTER SET PMF 1028 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760632 | FILTER SET PMF 2024 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760625 | FILTER SET PMF 1168 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760629 | FILTER SET PMF 100 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760638 | FILTER, PMF 1000 | Sorensen Research | KOC | Class II | 1976-10-15 |
| K760128 | TRAY, CATHETERIZATION W/ CATHETER | Concord Laboratories, Inc. | FCM | Class II | 1976-10-07 |
| K760105 | BAG, URINE COLLECTION, CLOSED SYSTEM | Concord Laboratories, Inc. | KNX | Class II | 1976-10-07 |
| K760127 | TRAY, CATHETERIZATION W/O CATHETER | Concord Laboratories, Inc. | FCM | Class II | 1976-10-07 |
| K760251 | SET, ORAL ADMINISTRATION | Cis Radiopharmaceuticals, Inc. | LEY | Class II | 1976-09-15 |
| K760274 | TIP, RUBBER, PERFORATED | V. Mueller O.V. Baxter Healthcare Corp. | FAJ | Class II | 1976-08-30 |
| K760174 | ADAPTER, RESECTOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | FDC | Class II | 1976-08-30 |
| K760452 | COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) | American Cystocope Makers, Inc. | FDF | Class II | 1976-08-30 |
| K760176 | FLOORSTAND, FIBER OPTIC LIGHT SOURCE | V. Mueller O.V. Baxter Healthcare Corp. | FCW | Class II | 1976-08-30 |
| K760451 | AIR WATER SOURCE (ACMI MODEL 710) | American Cystocope Makers, Inc. | OCX | Class II | 1976-08-30 |
| K760042 | BLOOD TUBING SETS | Bd Becton Dickinson Vacutainer Systems Preanalytic | KOC | Class II | 1976-08-30 |
| K760177 | TELESCOPE, RIGID ENDOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | FBP | Class II | 1976-08-30 |
| K760253 | TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG | C.R. Bard, Inc. | GBM | Class II | 1976-08-23 |
| K760259 | CATHETER 3-WAY SILICONE FOLEY | Travenol Laboratories, S.A. | KOD | Class II | 1976-08-23 |
| K760093 | CATHETER, SILICONE FOLEY (BARDEX) | C.R. Bard, Inc. | GBM | Class II | 1976-08-23 |
| K760254 | TRAY, FOLEY CATHETER | C.R. Bard, Inc. | GBM | Class II | 1976-08-23 |
| K760277 | UNDERPAD CODE NO. 8453 | Johnson & Johnson Professionals, Inc. | EYQ | Class I | 1976-08-11 |
| K760164 | UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) | Parke-Davis Co. | EYQ | Class I | 1976-07-20 |
| K760137 | TUBE, FEEDING, ARGYLE | Sherwood Medical Industries | FPD | Class II | 1976-07-16 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.