PLJClass III

Tissue Adhesive Internal Use

21 CFR 878.4010 / General, Plastic Surgery

PLJ is the FDA product code for Tissue Adhesive Internal Use, a class III device type, regulated under 21 CFR 878.4010. FDA's definition for this code reads: "Intended for the fixation of surgical meshes". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PLJ
Device name: Tissue Adhesive Internal Use
FDA definition: Intended for the fixation of surgical meshes.
Regulation: 21 CFR 878.4010
Device class: Class III
Review panel: General, Plastic Surgery
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PLJ

FDA records hold no clearances under product code PLJ.

Recent recalls

Product code PLJ

FDA records show no recalls under product code PLJ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)