FDA product code FHG: Bell, Circumcision
FHG is the FDA product code for bell, circumcision. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under FHG, from 2 different applicants. The average 510(k) review took 80 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Bell, Circumcision |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FHG clearance
Top FHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 1 | 1991-07-02 |
| American Hospital Supply Corp. | 1 | 1977-07-11 |
Most recent FHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911272 | Edward Weck, Inc. | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | 1991-07-02 | 102 |
| K770873 | American Hospital Supply Corp. | CIRCUMCISION KIT | 1977-07-11 | 59 |
Recalls for FHG devices
openFDA lists no recalls for product code FHG.
Frequently asked questions
What is FDA product code FHG?
FHG is the FDA product code for bell, circumcision. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is FHG?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHG?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most FHG clearances?
Edward Weck, Inc. (1); American Hospital Supply Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHG
- Run a recall and safety report across every FHG manufacturer
- Watch product code FHG 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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