FFP
5 FDA 510(k) clearances · Product code
182 daysmedian time to decision
325 days90th percentile
5clearances measured
FDA profile
- Official device name
- Dilator, Rectal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5450
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ANOKRYO (K964634) | Mk Conquest Intl., Inc. | 1997-06-06 |
| COLONIC BALLOON DILATOR (K901426) | Telemed Systems, Inc. | 1990-06-21 |
| INAMED RHEMO-D (TM) DILATOR (K894618) | Inamed Development Co. | 1990-01-18 |
| COLONIC BALLOON DIALATORS (K884713) | Primrose Medical, Inc. | 1989-09-29 |
| COLORECTAL DILATOR (K830354) | Cleveland Medical Supply & Services | 1983-05-27 |
Track FFP automatically
Every clearance here is in the API, with alerts when new ones post.