510(k) Report

FDA product code · General and plastic surgery

Tissue Adhesive Internal Use

PLJClass III21 CFR 878.4010PMA required1 decision since 20230 recalls

1 FDA decision since 2023. No recall names this code.

Intended for the fixation of surgical meshes.

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 PLJ 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 · PLJ

3in 2023

2023: 32026 (partial year): 2
2007high 3 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PLJ

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

Recalls per year · PLJ

No recall names PLJ since 2007.

Adverse event reports per year · PLJ

2in 2025

2025: 2
2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code PLJ, 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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20233—00
20240—00
20250—02
20262—0—
FIG. 1 — PLJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PLJ? 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

Related product codes

Other codes under 21 CFR 878.4010.