FDA product code FON: Bag, Drainage, With Adhesive, Ostomy
FON is the FDA product code for bag, drainage, with adhesive, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FON, from 3 different applicants. The average 510(k) review took 43 days (median 46). FDA has posted 5 recalls for FON devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FON clearance
Top FON applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister, Inc. | 1 | 1980-08-12 |
| Atlantic Surgical | 1 | 1978-01-26 |
| Howmedica Corp. | 1 | 1977-06-28 |
Most recent FON clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801504 | Hollister, Inc. | HOLLISTER DRAINAGE POUCH | 1980-08-12 | 46 |
| K772366 | Atlantic Surgical | BAG, DRAINAGEW/ADHESIVE; PROSTHESIS | 1978-01-26 | 30 |
| K770826 | Howmedica Corp. | POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE | 1977-06-28 | 54 |
Recalls for FON devices
5 product recalls in 3 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-02-16.
| Year | Recalls |
|---|---|
| 2024 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code FON?
FON is the FDA product code for bag, drainage, with adhesive, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is FON?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FON?
Across 3 cleared submissions the average was 43 days from receipt to decision (median 46).
Which companies have the most FON clearances?
Hollister, Inc. (1); Atlantic Surgical (1); Howmedica Corp. (1).
Have FON devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2026-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code FON
- Run a recall and safety report across every FON manufacturer
- Watch product code FON for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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