Device, Incontinence, Urosheath Type, Sterile
FDA product code EXJ · Class I (low risk) · 21 CFR 876.5250 · Gastroenterology, Urology
22510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Sierra Laboratories, Inc. 5
- Convatec, A Division of E.R. Squibb & Sons 3
- Mentor Corp. 2
- Coloplast A/S 2
- Rochester Medical Corp 2
- Hollister, Inc. 2
- Medline Industries, LP 1
- Dbt Medical , Ltd. 1
- Mark Sullivan, M.D., P.C. 1
- Convatec, A Bristol-Myers Squibb Co. 1
- Advanced Care Medical Products 1
- General Polymers 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970465 | Bouser's UrinalEXJ · Traditional | General Polymers | 12/18/1997SE |
| K972100 | Vented External Male Urinary Catheter(Vented Cath 5000)EXJ · Traditional | Advanced Care Medical Products | 07/31/1997SE |
| K970966 | Comfort Cath Choice Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 04/22/1997SE |
| K963265 | Prosys Samec laEXJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 10/25/1996SE |
| K962900 | Self Retaining Male External Urinary CatheterEXJ · Traditional | Hollister, Inc. | 09/16/1996SE |
| K962413 | Comfort Cath Special Self Adhering Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 07/15/1996SE |
| K962384 | Comfort Sheath Reusable Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 07/15/1996SE |
| K952082 | Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional | Rochester Medical Corp. | 07/18/1995SE |
| K945628 | Clear Advantage IIEXJ · Traditional | Mentor Corp. | 07/06/1995SE |
| K951530 | Prosys Urihesive System laEXJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/12/1995SE |
| K950690 | Prosys Urihesice System NLEXJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 03/23/1995SE |
| K942941 | Conquest Male Continence SystemEXJ · Traditional | Convatec, A Bristol-Myers Squibb Co. | 03/17/1995SE |
| K946243 | Conveen(R) Self-Sealing Urisheath Male External CatheterEXJ · Traditional | Coloplast A/S | 02/13/1995SE |
| K940269 | Hollister Non-Rolled Self-Adhesive Urinary External CatheterEXJ · Traditional | Hollister, Inc. | 06/02/1994SE |
| K934266 | Comfort Cath Self Adhering Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 04/19/1994SE |
| K931156 | Cone CathEXJ · Traditional | Sierra Laboratories, Inc. | 07/01/1993SE |
| K923136 | Male External CatheterEXJ · Traditional | Rochester Medical Corp. | 12/03/1992SE |
| K924407 | Conveen(R) Self-Sealing Urisheath Male Exter CathEXJ · Traditional | Coloplast A/S | 09/23/1992SE |
| K913524 | Silicone Male External CatheterEXJ · Traditional | Mentor Corp. | 10/04/1991SE |
| K903715 | Condom SealEXJ · Traditional | Mark Sullivan, M.D., P.C. | 01/23/1991SE |
| K851682 | Safeseal Reusable Urinal SystemEXJ · Traditional | Dbt Medical , Ltd. | 06/24/1985SE |
| K772144 | Catheter, Disp., External, MaleEXJ · Traditional | Medline Industries, Inc. | 11/28/1977SE |