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510(k) K191461

Exofin Fusion Skin Closure System by Chemence Medical, Inc. — Product Code OMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2020
Date Received
June 3, 2019
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 Chemence Medical, Inc.

  • K212246 — Exofin Precision Pen (September 9, 2021)
  • K200264 — Exofin High Viscosity Topical Skin Adhesive (December 17, 2020)
  • K171442 — Exofin Fusion Skin Closure System (September 25, 2017)
  • K162352 — derma+flex QS High Viscosity Tissue Adhesive (December 22, 2016)
  • K050757 — FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUI (February 23, 2006)

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)
  • 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)
  • DEN090005 — PRINEO SKIN CLOSURE SYSTEM (April 30, 2010)