FDA product code HFF: Aspirator, Endometrial
HFF is the FDA product code for aspirator, endometrial. It is a Class II device, regulated under 21 CFR 884.1060 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 5 510(k) submissions under HFF, from 4 different applicants. The average 510(k) review took 230 days (median 226).
Classification
| Field | Value |
|---|---|
| Device name | Aspirator, Endometrial |
| Device class | Class II |
| Regulation | 21 CFR 884.1060 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HFF clearance
Top HFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Axcan Scientific Corp. | 2 | 1984-06-15 |
| Gynetics Medical Products NV | 1 | 2004-09-08 |
| Gynopharma, Inc. | 1 | 1991-04-05 |
| Wallach Surgical Devices, Inc. | 1 | 1991-01-31 |
Most recent HFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041237 | Gynetics Medical Products NV | ECHOSAMPLER | 2004-09-08 | 120 |
| K903002 | Gynopharma, Inc. | PROBET (TM) | 1991-04-05 | 270 |
| K902693 | Wallach Surgical Devices, Inc. | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER | 1991-01-31 | 226 |
| K831212 | Axcan Scientific Corp. | ENDOSCANN | 1984-06-15 | 428 |
| K820641 | Axcan Scientific Corp. | ACCURETTE | 1982-06-22 | 106 |
Recalls for HFF devices
openFDA lists no recalls for product code HFF.
Frequently asked questions
What is FDA product code HFF?
HFF is the FDA product code for aspirator, endometrial. It is a Class II device, regulated under 21 CFR 884.1060 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFF?
Class II, regulation 21 CFR 884.1060. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFF?
Across 5 cleared submissions the average was 230 days from receipt to decision (median 226).
Which companies have the most HFF clearances?
Axcan Scientific Corp. (2); Gynetics Medical Products NV (1); Gynopharma, Inc. (1); Wallach Surgical Devices, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFF
- Run a recall and safety report across every HFF manufacturer
- Watch product code HFF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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