Protector, Ostomy
The ostomy protector is a device worn over a stoma to shield it from physical trauma, contact sports, or workplace hazards while allowing the patient to maintain an active lifestyle. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket submission. The product code is EXE, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No special regulatory flags apply.
Basic Information
- Product Code
- EXE
- Device Class
- FDA class 1
- Regulation Number
- 876.5900
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904233 | CONVATEC ABSORBENT BANDAGE | Mar 06, 1991 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K770982 | UNITED SKIN BARRIER | Jul 15, 1977 | Substantially Equivalent | HOWMEDICA CORP. |
| K760927 | STOMA SHIELD ADAPTER | Jan 26, 1977 | Substantially Equivalent | RUDOLFO T. SANCHEZ |
FEI Numbers
This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.