FDA product code NMK: Trocar, Reprocessed
NMK is the FDA product code for trocar, reprocessed. It is a Class II device, regulated under 21 CFR 870.1390 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under NMK. The average 510(k) review took 268 days (median 268).
Definition
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 | Trocar, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1390 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NMK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 268 |
Compare with all 510(k) review times · Search every NMK clearance
Top NMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 1 | 2020-07-22 |
Most recent NMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192998 | Innovative Health, LLC | Reprocessed BRK Transseptal Needle | 2020-07-22 | 268 |
Recalls for NMK devices
openFDA lists no recalls for product code NMK.
Frequently asked questions
What is FDA product code NMK?
NMK is the FDA product code for trocar, reprocessed. It is a Class II device, regulated under 21 CFR 870.1390 and reviewed by the Cardiovascular panel.
What device class is NMK?
Class II, regulation 21 CFR 870.1390. Typical premarket route: 510(k).
How long does a 510(k) take for product code NMK?
Across 1 cleared submissions the average was 268 days from receipt to decision (median 268).
Which companies have the most NMK clearances?
Innovative Health, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NMK
- Run a recall and safety report across every NMK manufacturer
- Watch product code NMK 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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