FDA product code NWJ: Suture, Recombinant Technology
NWJ is the FDA product code for suture, recombinant technology. It is a Class II device, regulated under 21 CFR 878.4494 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under NWJ, from 4 different applicants. The average 510(k) review took 62 days (median 58). 1 De Novo request was granted under it. FDA has posted 1 recall for NWJ devices.
Definition
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Recombinant Technology |
| Device class | Class II |
| Regulation | 21 CFR 878.4494 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 28 |
Compare with all 510(k) review times · Search every NWJ clearance
Top NWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tepha, Inc. | 4 | 2021-05-27 |
| Tornier, Inc. | 2 | 2013-04-04 |
| Aesculap, Inc. | 1 | 2010-07-14 |
| Entrigue Surgical, Inc. | 1 | 2007-11-16 |
Most recent NWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211307 | Tepha, Inc. | GalaSTITCH Absorbable Monofilament Suture | 2021-05-27 | 28 |
| K132348 | Tepha, Inc. | TEPHAFLEX BRAIDED SUTURE | 2013-09-05 | 38 |
| K130422 | Tornier, Inc. | PHANTOM FIBER BIOFIBER SUTURE | 2013-04-04 | 43 |
| K122487 | Tornier, Inc. | BIOFIBER SYTURE | 2012-09-17 | 33 |
| K100876 | Aesculap, Inc. | AESCULAP MONOMAX ABSORBABLE SUTURE | 2010-07-14 | 106 |
Recalls for NWJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-08.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NWJ?
NWJ is the FDA product code for suture, recombinant technology. It is a Class II device, regulated under 21 CFR 878.4494 and reviewed by the General and Plastic Surgery panel.
What device class is NWJ?
Class II, regulation 21 CFR 878.4494. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWJ?
Across 8 cleared submissions the average was 62 days from receipt to decision (median 58).
Which companies have the most NWJ clearances?
Tepha, Inc. (4); Tornier, Inc. (2); Aesculap, Inc. (1); Entrigue Surgical, Inc. (1).
Have NWJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-02-08.
Next steps
- Run an FDA pathway report with predicate devices for product code NWJ
- Run a recall and safety report across every NWJ manufacturer
- Watch product code NWJ 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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