Device, Paste-On For Incontinence, Sterile
The sterile paste-on incontinence device is an external adhesive device applied to the skin to manage urinary incontinence by creating a seal around the urethral meatus or perineal area to contain or direct urinary leakage. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EXI, regulated under 21 CFR 876.5250 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EXI
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971499 | FEMALE EXTERNAL URINARY COLLECTION POUCH | Aug 28, 1997 | Substantially Equivalent | Mediquest, Inc. |
| K970443 | HOLLISTER RETRACTED PENIS POUCH | Feb 25, 1997 | Substantially Equivalent | Hollister, Inc. |
| K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | Jan 10, 1997 | Substantially Equivalent | Bioderm, Inc. |
| K931277 | HOLLISTER PREMIUM URINE COLLECTOR | Jun 23, 1993 | Substantially Equivalent | Hollister, Inc. |
| K924755 | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION | Jun 22, 1993 | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons |
| K915246 | CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) | Feb 05, 1992 | Substantially Equivalent | Coloplast A/S |
| K915616 | URIHESIVE STRIP | Jan 23, 1992 | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.