HFF
5 FDA 510(k) clearances · Product code
226 daysmedian time to decision
428 days90th percentile
5clearances measured
FDA profile
- Official device name
- Aspirator, Endometrial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1060
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- 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 |
|---|---|---|
| ECHOSAMPLER (K041237) | Gynetics Medical Products NV | 2004-09-08 |
| PROBET (TM) (K903002) | Gynopharma, Inc. | 1991-04-05 |
| WALLACH FLEXIBLE ENDOMETRIAL SAMPLER (K902693) | Wallach Surgical Devices, Inc. | 1991-01-31 |
| ENDOSCANN (K831212) | Axcan Scientific Corp. | 1984-06-15 |
| ACCURETTE (K820641) | Axcan Scientific Corp. | 1982-06-22 |
Track HFF automatically
Every clearance here is in the API, with alerts when new ones post.