FDA Product Code
FDA Product Code EXJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5250
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970465 | BOUSER'S URINAL | General Polymers | 1997-12-18 | Traditional | PDF ↗ |
| K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | Advanced Care Medical Products | 1997-07-31 | Traditional | PDF ↗ |
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1997-04-22 | Traditional | PDF ↗ |
| K963265 | PROSYS SAMEC LA | Convatec, A Division of E.R. Squibb & Sons | 1996-10-25 | Traditional | PDF ↗ |
| K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER | Hollister, Inc. | 1996-09-16 | Traditional | PDF ↗ |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | Rochester Medical Corp. | 1995-07-18 | Traditional | PDF ↗ |
| K945628 | CLEAR ADVANTAGE II | Mentor Corp. | 1995-07-06 | Traditional | PDF ↗ |
| K951530 | PROSYS URIHESIVE SYSTEM LA | Convatec, A Division of E.R. Squibb & Sons | 1995-05-12 | Traditional | PDF ↗ |
| K950690 | PROSYS URIHESICE SYSTEM NL | Convatec, A Division of E.R. Squibb & Sons | 1995-03-23 | Traditional | PDF ↗ |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Convatec, A Bristol-Myers Squibb Co. | 1995-03-17 | Traditional | PDF ↗ |
| K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER | Coloplast A/S | 1995-02-13 | Traditional | PDF ↗ |
| K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER | Hollister, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K931156 | CONE CATH | Sierra Laboratories, Inc. | 1993-07-01 | Traditional | PDF ↗ |
| K923136 | MALE EXTERNAL CATHETER | Rochester Medical Corp. | 1992-12-03 | Traditional | PDF ↗ |
| K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH | Coloplast A/S | 1992-09-23 | Traditional | PDF ↗ |
| K913524 | SILICONE MALE EXTERNAL CATHETER | Mentor Corp. | 1991-10-04 | Traditional | PDF ↗ |
| K903715 | CONDOM SEAL | Mark Sullivan, M.D., P.C. | 1991-01-23 | Traditional | PDF ↗ |
| K851682 | SAFESEAL REUSABLE URINAL SYSTEM | Dbt Medical , Ltd. | 1985-06-24 | Traditional | PDF ↗ |
| K772144 | CATHETER, DISP., EXTERNAL, MALE | Medline Industries, Inc. | 1977-11-28 | Traditional | PDF ↗ |
Product code EXJ · Class I · Gastroenterology, Urology. Data: openFDA.