FDA product code NJU: Suture, Nonabsorbable, Nitinol
NJU is the FDA product code for suture, nonabsorbable, nitinol. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under NJU, from 2 different applicants. The average 510(k) review took 85 days (median 85).
Definition
Soft tissue approximation.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Nitinol |
| Device class | Class II |
| Regulation | 21 CFR 878.4495 |
| 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 NJU clearance
Top NJU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Onux Medical, Inc. | 1 | 2002-12-27 |
| Coalescent Surgical | 1 | 2002-12-18 |
Most recent NJU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023372 | Onux Medical, Inc. | NON-BIOABSORBABLE STAPLE | 2002-12-27 | 80 |
| K023125 | Coalescent Surgical | COALESCENT U-CLIP- AND ACCESSORIES | 2002-12-18 | 90 |
Recalls for NJU devices
openFDA lists no recalls for product code NJU.
Frequently asked questions
What is FDA product code NJU?
NJU is the FDA product code for suture, nonabsorbable, nitinol. It is a Class II device, regulated under 21 CFR 878.4495 and reviewed by the General and Plastic Surgery panel.
What device class is NJU?
Class II, regulation 21 CFR 878.4495. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJU?
Across 2 cleared submissions the average was 85 days from receipt to decision (median 85).
Which companies have the most NJU clearances?
Onux Medical, Inc. (1); Coalescent Surgical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJU
- Run a recall and safety report across every NJU manufacturer
- Watch product code NJU 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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