FDA product code NVH: Suture, Knot, Mechanical
NVH is the FDA product code for suture, knot, mechanical. 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 NVH. The average 510(k) review took 51 days (median 51).
Definition
In approximation and/or ligation of soft tissue
Classification
| Field | Value |
|---|---|
| Device name | Suture, Knot, Mechanical |
| 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 NVH clearance
Top NVH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicinelodge, Inc. | 1 | 2005-07-27 |
Most recent NVH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051488 | Medicinelodge, Inc. | MEDICINELODGE ZIPKNOT | 2005-07-27 | 51 |
Recalls for NVH devices
openFDA lists no recalls for product code NVH.
Frequently asked questions
What is FDA product code NVH?
NVH is the FDA product code for suture, knot, mechanical. 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 NVH?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVH?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most NVH clearances?
Medicinelodge, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NVH
- Run a recall and safety report across every NVH manufacturer
- Watch product code NVH 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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