FDA product code NMJ: Clip, Implantable, Reprocessed
NMJ is the FDA product code for clip, implantable, reprocessed. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NMJ. The average 510(k) review took 606 days (median 606).
Definition
The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Implantable, Reprocessed |
| 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 NMJ clearance
Top NMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clearmedical, Inc. | 1 | 2005-07-11 |
Most recent NMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033579 | Clearmedical, Inc. | REPROCESSED MULTIPLE CLIP APPLIERS | 2005-07-11 | 606 |
Recalls for NMJ devices
openFDA lists no recalls for product code NMJ.
Frequently asked questions
What is FDA product code NMJ?
NMJ is the FDA product code for clip, implantable, reprocessed. 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 NMJ?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NMJ?
Across 1 cleared submissions the average was 606 days from receipt to decision (median 606).
Which companies have the most NMJ clearances?
Clearmedical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NMJ
- Run a recall and safety report across every NMJ manufacturer
- Watch product code NMJ 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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