Home / 510(k) Clearances / DEN090005

510(k) DEN090005

PRINEO SKIN CLOSURE SYSTEM by Closure Medical Corp. — Product Code OMD

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 30, 2010
Date Received
March 24, 2009
Clearance Type
Post-NSE
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 Closure Medical Corp.

  • K002338 — LIQUIDERM LIQUID ADHESIVE BANDAGE (January 29, 2001)
  • K991923 — SOOTHE-N-SEAL CANKER SORE RELIEF (September 2, 1999)
  • K980159 — OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 (April 9, 1998)

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)
  • K163645 — DERMABOND PRINEO Skin Closure System (April 21, 2017)
  • K152490 — DERMABOND PRINEO Skin Closure System (November 25, 2015)
  • K133864 — DERMABOND PRINEO SKIN CLOSURE SYSTEM (March 10, 2014)