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510(k) K211878

LiquiBand XL by Advanced Medical Solutions Limited — Product Code OMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2022
Date Received
June 21, 2021
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 Advanced Medical Solutions Limited

  • K223310 — Antimicrobial Silicone PHMB Foam Wound Dressing (April 5, 2023)
  • K183570 — LiquiBand Plus (March 9, 2020)
  • K110458 — SILVER ANTIMICROBIAL WOUND GEL (March 14, 2011)
  • K091013 — SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (July 30, 2009)
  • K090453 — SILVER ALGINATE 11 WOUND DRESSING (February 26, 2009)
  • K080503 — SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (November 12, 2008)
  • K081363 — NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBI (September 24, 2008)
  • K073197 — SILVER ANTIMICROBIAL WOUND GEL (August 28, 2008)
  • K070581 — SILVER ALGINATE II WOUND DRESSING (July 13, 2007)
  • K063173 — MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (November 3, 2006)

Other clearances for product code OMD

  • K233460 — CM00622 LINC Skin Closure System (CM00622 LINC) (July 15, 2024)
  • 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)
  • DEN090005 — PRINEO SKIN CLOSURE SYSTEM (April 30, 2010)