Panels › Gastroenterology, Urology › Product code KNY · Class 2
Accessories, Catheter, G-U
Regulation 876.5130
1510(k)s in 12 months (65 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in KNY
| Company | 510(k)s | Recalls |
|---|---|---|
| Percutaneous Systems, Inc. | 5 | 0 |
| Lake Region Mfg., Inc. | 3 | 0 |
| Promepla Sam | 3 | 0 |
| Solace Therapeutics | 3 | 0 |
| Avail Medical Products, Inc. | 2 | 0 |
| Boston Scientific Corp | 2 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 2 | 0 |
| Kit Pak, Inc. | 2 | 0 |
| Medical Device Technologies, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 1991 | K913679 | UNIVERSAL SWIVEL PATCH Bryman Medical | KNY |
| Jul 26, 1991 | K912146 | URETERAL CATHETER HOLDER Inman Liebelt Corp. | KNY |
| Nov 29, 1990 | K905128 | FLEXI-TRAK(TM) ANCHORING DEVICE Convatec, A Division of E.R. Squibb & Sons | KNY |
| Mar 6, 1990 | K900031 | MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS Porges Corp. | KNY |
| Feb 26, 1990 | K896806 | CATHETER PLUG/PROTECTOR Westmark, Sterile Packing Systems, Inc. (Sps) | KNY |
| Jun 12, 1989 | K890072 | PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE Medireach, Inc. | KNY |
| Feb 17, 1989 | K884819 | O'NEIL URINARY CATHETER INTRODUCER Medical Marketing Group | KNY |
| Jul 28, 1988 | K881878 | CATHETER WITHDRAWAL UNIT Eris Medical Technology | KNY |
| Jul 12, 1988 | K882641 | TECNOL CATHETER LEG STRAP Tecnol New Jersey Wound Care, Inc. | KNY |
| Nov 27, 1987 | K873288 | CLOSED FOLEY CATHETER SYSTEM Todd Medical, Inc. | KNY |
| Oct 19, 1983 | K833242 | DEFLECTING GUIDE WIRE Van-Tec, Inc. | KNY |
| May 21, 1982 | K821336 | TRANSENDOSCOPIC INJECTION CATHETER TEI Sounson Research Co., Inc. | KNY |
| Dec 4, 1978 | K781987 | URINARY DRAINAGE BAG Kelsar Corp. | KNY |
| Sep 12, 1977 | K771212 | SAFEED DISP. PLASTIC CATHETER Terumo America, Inc. | KNY |
| Nov 23, 1976 | K760943 | SILASTIC BRAND GASTRIC LAVAGE TUBE Dow Corning Corp. Healthcare Industries Materials | KNY |
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