FDA Product Code
FDA Product Code FFP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5450
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964634 | ANOKRYO | Mk Conquest Intl., Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K901426 | COLONIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Inamed Development Co. | 1990-01-18 | Traditional | PDF ↗ |
| K884713 | COLONIC BALLOON DIALATORS | Primrose Medical, Inc. | 1989-09-29 | Traditional | PDF ↗ |
| K830354 | COLORECTAL DILATOR | Cleveland Medical Supply & Services | 1983-05-27 | Traditional | PDF ↗ |
Product code FFP · Class I · Gastroenterology, Urology. Data: openFDA.