FDA product code NJC: Clip, Vas Deferens
NJC is the FDA product code for clip, vas deferens. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under NJC, from 2 different applicants. The average 510(k) review took 76 days (median 76).
Definition
This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Vas Deferens |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NJC clearance
Top NJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gyrx, LLC | 1 | 2004-03-05 |
| Vmbc, LLC | 1 | 2002-08-20 |
Most recent NJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K034029 | Gyrx, LLC | TI CLIP APPLIER | 2004-03-05 | 67 |
| K021745 | Vmbc, LLC | VASCLIP | 2002-08-20 | 84 |
Recalls for NJC devices
openFDA lists no recalls for product code NJC.
Frequently asked questions
What is FDA product code NJC?
NJC is the FDA product code for clip, vas deferens. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is NJC?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJC?
Across 2 cleared submissions the average was 76 days from receipt to decision (median 76).
Which companies have the most NJC clearances?
Gyrx, LLC (1); Vmbc, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJC
- Run a recall and safety report across every NJC manufacturer
- Watch product code NJC 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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