Product code EXJ
- Device name
- Device, Incontinence, Urosheath Type, Sterile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5250
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970465 | BOUSER'S URINAL | General Polymers | 1997-12-18 |
| K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | Advanced Care Medical Products | 1997-07-31 |
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1997-04-22 |
| K963265 | PROSYS SAMEC LA | Convatec, A Division of E.R. Squibb & Sons | 1996-10-25 |
| K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER | Hollister, Inc. | 1996-09-16 |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | Rochester Medical Corp. | 1995-07-18 |
| K945628 | CLEAR ADVANTAGE II | Mentor Corp. | 1995-07-06 |
| K951530 | PROSYS URIHESIVE SYSTEM LA | Convatec, A Division of E.R. Squibb & Sons | 1995-05-12 |
| K950690 | PROSYS URIHESICE SYSTEM NL | Convatec, A Division of E.R. Squibb & Sons | 1995-03-23 |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Convatec, A Bristol-Myers Squibb Co. | 1995-03-17 |
| K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER | Coloplast A/S | 1995-02-13 |
| K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER | Hollister, Inc. | 1994-06-02 |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1994-04-19 |
| K931156 | CONE CATH | Sierra Laboratories, Inc. | 1993-07-01 |
| K923136 | MALE EXTERNAL CATHETER | Rochester Medical Corp. | 1992-12-03 |
| K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH | Coloplast A/S | 1992-09-23 |
| K913524 | SILICONE MALE EXTERNAL CATHETER | Mentor Corp. | 1991-10-04 |
| K903715 | CONDOM SEAL | Mark Sullivan, M.D., P.C. | 1991-01-23 |
| K851682 | SAFESEAL REUSABLE URINAL SYSTEM | Dbt Medical , Ltd. | 1985-06-24 |
| K772144 | CATHETER, DISP., EXTERNAL, MALE | Medline Industries, Inc. | 1977-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253030181 | Dover | Cardinal Health 200, LLC | 2025-04-01 |
| 10192253030099 | Dover | Cardinal Health 200, LLC | 2024-12-17 |
| 10192253030020 | Dover | Cardinal Health 200, LLC | 2024-12-17 |
| 10192253030037 | Dover | Cardinal Health 200, LLC | 2024-10-15 |
| 06944932725508 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06944932725492 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06944932725485 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06936881133459 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06936881133435 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06936881133398 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06936881133381 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-11 |
| 06936881133527 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-10 |
| 06936881133503 | Wellead Male External Catheter | Well Lead Medical Co.,Ltd | 2023-07-10 |
| 10884521003620 | Dover | Cardinal Health, Inc. | 2018-06-30 |
| 10884521007864 | Dover | Cardinal Health, Inc. | 2018-06-30 |
| 10884521050433 | Dover | Cardinal Health, Inc. | 2018-06-30 |
| 20884521003986 | Dover | Cardinal Health, Inc. | 2018-06-30 |
| 10884521003873 | Dover | Cardinal Health, Inc. | 2018-06-27 |
| 20884521157023 | Dover | Cardinal Health, Inc. | 2018-06-27 |
| 00792293985163 | Uro-Kit® Reusable Latex Leg Bag System 16 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985095 | Uro-Kit® Reusable Latex Leg Bag System 9 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293995100 | Uro-Kit® Reusable Latex Leg Bag System 10 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985323 | Uro-Kit® Reusable Latex Leg Bag System 32 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985262 | Uro-Kit® Reusable Latex Leg Bag System 26 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985187 | Uro-Kit® Reusable Latex Leg Bag System 18 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985101 | Uro-Kit® Reusable Latex Leg Bag System 10 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293995445 | Uro-Kit® Reusable Latex Leg Bag System 44 oz. | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 00792293995322 | Uro-Kit® Reusable Latex Leg Bag System 32 oz. | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 00792293995261 | Uro-Kit® Reusable Latex Leg Bag System 26 oz. | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 00792293995162 | Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.) | UROCARE PRODUCTS, INC. | 2018-04-09 |