Panels › Gastroenterology, Urology › Product code FON · Class 1
Bag, Drainage, With Adhesive, Ostomy
Regulation 876.5900
0510(k)s in 12 months (3 all time)
3recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in FON
| Company | 510(k)s | Recalls |
|---|---|---|
| ConvaTec, Inc | 0 | 5 |
| Atlantic Surgical | 1 | 0 |
| Hollister, Inc. | 1 | 0 |
| Howmedica Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | ConvaTec, Inc Convatec, EsteemBody Drainable Pouch
REF:423657
10-35mm Open, Classified |
FON | None listed |
| Mar 19, 2026 | ConvaTec, Inc Convatec, EsteemBody Drainable Pouch
REF:423653
10-35mm Open, Classified |
FON | None listed |
| Mar 19, 2026 | ConvaTec, Inc Convatec, EsteemBody Drainable Pouch
REF:423643,
10-45mm Open, Classified |
FON | None listed |
| Sep 30, 2024 | ConvaTec, Inc ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. Open, Classified |
FON | None listed |
| Mar 21, 2024 | ConvaTec, Inc Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 4236 Open, Classified |
FON | None listed |
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