FDA product code HFL: Drain, Cervical
HFL is the FDA product code for drain, cervical. It is a Class II device, regulated under 21 CFR 884.3200 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HFL. The average 510(k) review took 155 days (median 155).
Classification
| Field | Value |
|---|---|
| Device name | Drain, Cervical |
| Device class | Class II |
| Regulation | 21 CFR 884.3200 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HFL clearance
Top HFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sil-Med Corp. | 1 | 1991-01-31 |
Most recent HFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903989 | Sil-Med Corp. | SIL-MED T-TUBE DRAIN | 1991-01-31 | 155 |
Recalls for HFL devices
openFDA lists no recalls for product code HFL.
Frequently asked questions
What is FDA product code HFL?
HFL is the FDA product code for drain, cervical. It is a Class II device, regulated under 21 CFR 884.3200 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFL?
Class II, regulation 21 CFR 884.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HFL?
Across 1 cleared submissions the average was 155 days from receipt to decision (median 155).
Which companies have the most HFL clearances?
Sil-Med Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFL
- Run a recall and safety report across every HFL manufacturer
- Watch product code HFL 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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