510(k) Report

FDA product code · General and plastic surgery

Clip, Implantable, Reprocessed

NMJClass II21 CFR 878.4300510(k) required1 decision since 20050 recalls

1 FDA decision since 2005. No recall names this code.

The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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 NMJ 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 · NMJ

FDA has decided no NMJ device since 2007.

Median 510(k) review, days · NMJ

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

Recalls per year · NMJ

No recall names NMJ since 2007.

Adverse event reports per year · NMJ

11in 2021

2011: 22012: 902013: 442014: 642015: 112016: 122017: 42018: 72019: 112020: 12021: 11
2007high 90 (2012) · low 0 (2007)2025

MAUDE reports naming product code NMJ, not matched to any one device; reports are not rates.

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—02
20120—090
20130—044
20140—064
20150—011
20160—012
20170—04
20180—07
20190—011
20200—01
20210—011
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NMJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NMJ? 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 NMJ devices have the deepest lineage?

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

  • K033579Reprocessed Multiple Clip AppliersClearmedical, Inc. · 20051generation

What has FDA decided in NMJ lately?

  • K033579Reprocessed Multiple Clip AppliersClearmedical, Inc. · 2005

The one NMJ decision →

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