Panels › Gastroenterology, Urology › Product code EXJ · Class 1
Device, Incontinence, Urosheath Type, Sterile
Regulation 876.5250
0510(k)s in 12 months (22 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EXJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Sierra Laboratories, Inc. | 5 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 3 | 0 |
| Coloplast A/S | 2 | 0 |
| Hollister, Inc. | 2 | 0 |
| Mentor Corp. | 2 | 0 |
| Rochester Medical Corp. | 2 | 0 |
| Advanced Care Medical Products | 1 | 0 |
| Convatec, A Bristol-Myers Squibb Co. | 1 | 0 |
| Dbt Medical , Ltd. | 1 | 0 |
| General Polymers | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 1997 | K970465 | BOUSER'S URINAL General Polymers | EXJ |
| Jul 31, 1997 | K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) Advanced Care Medical Products | EXJ |
| Apr 22, 1997 | K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Oct 25, 1996 | K963265 | PROSYS SAMEC LA Convatec, A Division of E.R. Squibb & Sons | EXJ |
| Sep 16, 1996 | K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER Hollister, Inc. | EXJ |
| Jul 15, 1996 | K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Jul 15, 1996 | K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Jul 18, 1995 | K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER Rochester Medical Corp. | EXJ |
| Jul 6, 1995 | K945628 | CLEAR ADVANTAGE II Mentor Corp. | EXJ |
| May 12, 1995 | K951530 | PROSYS URIHESIVE SYSTEM LA Convatec, A Division of E.R. Squibb & Sons | EXJ |
| Mar 23, 1995 | K950690 | PROSYS URIHESICE SYSTEM NL Convatec, A Division of E.R. Squibb & Sons | EXJ |
| Mar 17, 1995 | K942941 | CONQUEST MALE CONTINENCE SYSTEM Convatec, A Bristol-Myers Squibb Co. | EXJ |
| Feb 13, 1995 | K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER Coloplast A/S | EXJ |
| Jun 2, 1994 | K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER Hollister, Inc. | EXJ |
| Apr 19, 1994 | K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER Sierra Laboratories, Inc. | EXJ |
| Jul 1, 1993 | K931156 | CONE CATH Sierra Laboratories, Inc. | EXJ |
| Dec 3, 1992 | K923136 | MALE EXTERNAL CATHETER Rochester Medical Corp. | EXJ |
| Sep 23, 1992 | K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH Coloplast A/S | EXJ |
| Oct 4, 1991 | K913524 | SILICONE MALE EXTERNAL CATHETER Mentor Corp. | EXJ |
| Jan 23, 1991 | K903715 | CONDOM SEAL Mark Sullivan, M.D., P.C. | EXJ |
| Jun 24, 1985 | K851682 | SAFESEAL REUSABLE URINAL SYSTEM Dbt Medical , Ltd., GB | EXJ |
| Nov 28, 1977 | K772144 | CATHETER, DISP., EXTERNAL, MALE Medline Industries, Inc. | EXJ |
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