Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5900](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5900) → FON — Bag, Drainage, With Adhesive, Ostomy

# FON · Bag, Drainage, With Adhesive, Ostomy

_Gastroenterology, Urology · 21 CFR 876.5900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FON

## Overview

- **Product Code:** FON
- **Device Name:** Bag, Drainage, With Adhesive, Ostomy
- **Regulation:** [21 CFR 876.5900](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5900)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K801504](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FON/K801504.md) | HOLLISTER DRAINAGE POUCH | Hollister, Inc. | Aug 12, 1980 | SESE |
| [K772366](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FON/K772366.md) | BAG, DRAINAGEW/ADHESIVE; PROSTHESIS | Atlantic Surgical | Jan 26, 1978 | SESE |
| [K770826](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FON/K770826.md) | POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE | Howmedica Corp. | Jun 28, 1977 | SESE |

## Top Applicants

- Atlantic Surgical — 1 clearance
- Hollister, Inc. — 1 clearance
- Howmedica Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FON](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FON)

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