FFP — Dilator, Rectal Class I
FDA product code FFP covers "Dilator, Rectal", a Class I medical device regulated under 21 CFR 876.5450. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FFP
- Device Class
- Class I
- Regulation Number
- 876.5450
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K964634 | mk conquest intl | ANOKRYO | June 6, 1997 |
| K901426 | telemed systems | COLONIC BALLOON DILATOR | June 21, 1990 |
| K894618 | inamed development | INAMED RHEMO-D (TM) DILATOR | January 18, 1990 |
| K884713 | primrose medical | COLONIC BALLOON DIALATORS | September 29, 1989 |
| K830354 | cleveland medical supply and services | COLORECTAL DILATOR | May 27, 1983 |