Device, Incontinence, Urosheath Type, Sterile
The sterile urosheath-type incontinence device is an external condom catheter or penile sheath system designed to collect urine in male patients with urinary incontinence, connecting to a drainage bag via tubing. It is classified as FDA Class 1, indicating minimal risk, requiring only general controls. The product code is EXJ, regulated under 21 CFR 876.5250 in the Gastroenterology, Urology specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EXJ
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970465 | BOUSER'S URINAL | Dec 18, 1997 | Substantially Equivalent | General Polymers |
| K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | Jul 31, 1997 | Substantially Equivalent | Advanced Care Medical Products |
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Apr 22, 1997 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K963265 | PROSYS SAMEC LA | Oct 25, 1996 | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons |
| K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER | Sep 16, 1996 | Substantially Equivalent | Hollister, Inc. |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Jul 15, 1996 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Jul 15, 1996 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | Jul 18, 1995 | Substantially Equivalent | Rochester Medical Corp. |
| K945628 | CLEAR ADVANTAGE II | Jul 06, 1995 | Substantially Equivalent | Mentor Corp. |
| K951530 | PROSYS URIHESIVE SYSTEM LA | May 12, 1995 | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons |
| K950690 | PROSYS URIHESICE SYSTEM NL | Mar 23, 1995 | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Mar 17, 1995 | Substantially Equivalent | Convatec, A Bristol-Myers Squibb Co. |
| K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER | Feb 13, 1995 | Substantially Equivalent | Coloplast A/S |
| K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER | Jun 02, 1994 | Substantially Equivalent | Hollister, Inc. |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Apr 19, 1994 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K931156 | CONE CATH | Jul 01, 1993 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K923136 | MALE EXTERNAL CATHETER | Dec 03, 1992 | Substantially Equivalent | Rochester Medical Corp. |
| K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH | Sep 23, 1992 | Substantially Equivalent | Coloplast A/S |
| K913524 | SILICONE MALE EXTERNAL CATHETER | Oct 04, 1991 | Substantially Equivalent | Mentor Corp. |
| K903715 | CONDOM SEAL | Jan 23, 1991 | Substantially Equivalent | Mark Sullivan, M.D., P.C. |
| K851682 | SAFESEAL REUSABLE URINAL SYSTEM | Jun 24, 1985 | Substantially Equivalent | Dbt Medical , Ltd. |
| K772144 | CATHETER, DISP., EXTERNAL, MALE | Nov 28, 1977 | Substantially Equivalent | Medline Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.