FDA product code FHJ: Shield, Circumcision
FHJ is the FDA product code for shield, 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 FHJ, from 2 different applicants. The average 510(k) review took 102 days (median 102).
Classification
| Field | Value |
|---|---|
| Device name | Shield, 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 FHJ clearance
Top FHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kedumin Kits, Ltd. | 1 | 1990-11-05 |
| Shofu Dental Corp. | 1 | 1983-05-09 |
Most recent FHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902119 | Kedumin Kits, Ltd. | SAFEBRIS STERILE CIRCUMCISION KIT | 1990-11-05 | 180 |
| K831229 | Shofu Dental Corp. | SUPER SNAPS | 1983-05-09 | 24 |
Recalls for FHJ devices
openFDA lists no recalls for product code FHJ.
Frequently asked questions
What is FDA product code FHJ?
FHJ is the FDA product code for shield, 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 FHJ?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHJ?
Across 2 cleared submissions the average was 102 days from receipt to decision (median 102).
Which companies have the most FHJ clearances?
Kedumin Kits, Ltd. (1); Shofu Dental Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHJ
- Run a recall and safety report across every FHJ manufacturer
- Watch product code FHJ 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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