510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NJUClass II

Suture, Nonabsorbable, Nitinol

21 CFR 878.4495 / General, Plastic Surgery
FDA source (opens on fda.gov)

NJU is the FDA product code for Suture, Nonabsorbable, Nitinol, a class II device type, regulated under 21 CFR 878.4495. FDA's definition for this code reads: "Soft tissue approximation". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NJU
Device name
Suture, Nonabsorbable, Nitinol
FDA definition
Soft tissue approximation.
Regulation
21 CFR 878.4495
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
2
Ingested recalls
0

Clearances, product code NJU

By decision year
2 clearances under product code NJU with a decision year between 2002 and 2002, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NJU by decision year
YearClearances
20022

Applicants with the most clearances

Product code NJU
Applicants holding the most 510(k) clearances under product code NJU
ApplicantClearances
Coalescent Surgical1
Onux Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NJU.