510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NWJClass II

Suture, Recombinant Technology

21 CFR 878.4494 / General, Plastic Surgery
FDA source (opens on fda.gov)

NWJ is the FDA product code for Suture, Recombinant Technology, a class II device type, regulated under 21 CFR 878.4494. FDA's definition for this code reads: "Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NWJ
Device name
Suture, Recombinant Technology
FDA definition
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Regulation
21 CFR 878.4494
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
1

Clearances, product code NWJ

By decision year
9 clearances under product code NWJ with a decision year between 2007 and 2021, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NWJ by decision year
YearClearances
20072
20082
20101
20121
20132
20211

Applicants with the most clearances

Product code NWJ
Applicants holding the most 510(k) clearances under product code NWJ
ApplicantClearances
Tepha, Inc.4
TORNIER Inc.2
Aesculap Inc1
Entrigue Surgical, Inc.1
Tepha, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code