FDA product code HFD: Washer, Endometrial
HFD is the FDA product code for washer, endometrial. It is a Class II device, regulated under 21 CFR 884.1185 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 3 510(k) submissions under HFD, from 3 different applicants. The average 510(k) review took 22 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Washer, Endometrial |
| Device class | Class II |
| Regulation | 21 CFR 884.1185 |
| 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 HFD clearance
Top HFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-03-17 |
| Kinetic Medical Products | 1 | 1989-02-27 |
| Associated Medical Products Co. | 1 | 1981-03-17 |
Most recent HFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891037 | Zinnanti Surgical Instruments, Inc. | WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE | 1989-03-17 | 17 |
| K890376 | Kinetic Medical Products | VAGINAL SPECULUM | 1989-02-27 | 35 |
| K810558 | Associated Medical Products Co. | SKIN SCRUB TRAY | 1981-03-17 | 15 |
Recalls for HFD devices
openFDA lists no recalls for product code HFD.
Frequently asked questions
What is FDA product code HFD?
HFD is the FDA product code for washer, endometrial. It is a Class II device, regulated under 21 CFR 884.1185 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFD?
Class II, regulation 21 CFR 884.1185. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFD?
Across 3 cleared submissions the average was 22 days from receipt to decision (median 17).
Which companies have the most HFD clearances?
Zinnanti Surgical Instruments, Inc. (1); Kinetic Medical Products (1); Associated Medical Products Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFD
- Run a recall and safety report across every HFD manufacturer
- Watch product code HFD 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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