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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 1980 | K801504 | HOLLISTER DRAINAGE POUCH Hollister, Inc. | FON |
| Jan 26, 1978 | K772366 | BAG, DRAINAGEW/ADHESIVE; PROSTHESIS Atlantic Surgical | FON |
| Jun 28, 1977 | K770826 | POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE Howmedica Corp. | FON |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.