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
K213512Substantially Equivalent

DERMABOND PRINEO Skin Closure System

Ethicon, Inc, Raritan NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213512 is the FDA 510(k) clearance record for DERMABOND PRINEO Skin Closure System, a class II device, cleared for ETHICON, Inc. on under FDA product code OMD (Cutaneous Tissue Adhesive With Mesh). FDA's definition for product code OMD reads: "For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The...". FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K213512.

Clearance record

Decision date
Received
(35 days to decision)
Product code
OMD Cutaneous Tissue Adhesive With Mesh
Regulation
21 CFR 878.4011
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. 1000 Rte. 202 S., Raritan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMD

Trailing 12 months

FDA records hold no clearances under product code OMD in the trailing twelve months.

FDA records show no clearances under product code OMD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260