510(k) K163645

DERMABOND PRINEO Skin Closure System by Ethicon, LLC — Product Code OMD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 21, 2017
Date Received: December 23, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cutaneous Tissue Adhesive With Mesh
Device Class: Class II
Regulation Number: 878.4011
Review Panel: SU
Submission Type

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 device may be used in conjunction with, but not in place of, deep dermal sutures.

Other clearances by Ethicon, LLC

K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthet (February 6, 2026)
K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MO (December 22, 2025)
K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (November 15, 2022)
K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu (February 22, 2022)
K213512 — DERMABOND PRINEO Skin Closure System (December 7, 2021)
K201996 — Monocryl Plus Antibacterial Suture (December 21, 2020)
K201686 — GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT (September 17, 2020)
K201143 — VICRYL Mesh (August 6, 2020)
K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (March 25, 2020)

Other clearances for product code OMD

K233460 — CM00622 LINC Skin Closure System (CM00622 LINC) (July 15, 2024)
K211878 — LiquiBand XL (May 23, 2022)
K213512 — DERMABOND PRINEO Skin Closure System (December 7, 2021)
K191461 — Exofin Fusion Skin Closure System (June 5, 2020)
K171442 — Exofin Fusion Skin Closure System (September 25, 2017)
K152490 — DERMABOND PRINEO Skin Closure System (November 25, 2015)
K133864 — DERMABOND PRINEO SKIN CLOSURE SYSTEM (March 10, 2014)
DEN090005 — PRINEO SKIN CLOSURE SYSTEM (April 30, 2010)