510(k) Report

FDA product code · General and plastic surgery

Suture, Nonabsorbable, Nitinol

NJUClass II21 CFR 878.4495510(k) required2 decisions since 20020 recalls

2 FDA decisions since 2002. No recall names this code. The most-cited predicate is K023125, named by 6 later devices.

Soft tissue approximation.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of NJU at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NJU

FDA has decided no NJU device since 2007.

Median 510(k) review, days · NJU

Too few NJU 510(k)s in any year since 2007 to give a median.

Recalls per year · NJU

No recall names NJU since 2007.

Adverse event reports per year · NJU

No MAUDE report names NJU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NJU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NJU? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NJU devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 20026cite it
  • K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 20021cites it

Which NJU devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 20026generations
  • K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 20023generations

What has FDA decided in NJU lately?

  • K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002

All 2 NJU decisions →

Related product codes

Other codes under 21 CFR 878.4495.

GAQ Suture, Nonabsorbable, Steel, Monofilament And…PTX Suture, Nonabsorbable, Steel, Monofilament And…GAO Suture, Nonabsorbable