Bag, Drainage, With Adhesive, Ostomy
The Ostomy Drainage Bag with Adhesive is a pouch with an adhesive skin barrier that attaches around a stoma to collect intestinal or urinary output in patients who have undergone ostomy surgery. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FON, regulated under 21 CFR 876.5900 in the Gastroenterology and Urology specialty.
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Basic Information
- Product Code
- FON
- 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 |
|---|---|---|---|---|
| K801504 | HOLLISTER DRAINAGE POUCH | Aug 12, 1980 | Substantially Equivalent | Hollister, Inc. |
| K772366 | BAG, DRAINAGEW/ADHESIVE; PROSTHESIS | Jan 26, 1978 | Substantially Equivalent | Atlantic Surgical |
| K770826 | POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE | Jun 28, 1977 | Substantially Equivalent | Howmedica Corp. |
FEI Numbers
This FDA classification entry is associated with 88 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 88 registration numbers. Click on an entry to view related FDA registrations.