Avance Abdominal Dressing Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K161939 ↗

FDA Product Code

OXJ

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Avance Gauze Dressing Kits

  Class II

  FDA 510(k) K161948 Active Cleared 3 Nov 2016

• Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

  Class I

  FDA 510(k) K193573 Active Cleared 10 Apr 2020

• Biogel Orthopor Brown Surgical Glove

  Class I

  FDA 510(k) K112089 Active Cleared 24 Aug 2011

• Exufiber Ag+

  Unclassified

  FDA 510(k) K160379 Active Cleared 25 Aug 2016

• Biogel (R) Indicator (R) Underglove

  Class I

  FDA 510(k) K111413 Active Cleared 30 Jan 2012

• Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

  Class I

  FDA 510(k) K191869 Active Cleared 13 Mar 2020

See all devices from Molnlycke Health Care Us, LLC →

• What is the Avance Abdominal Dressing Kit used for?

  The Avance Abdominal Dressing Kit is intended for use in the repair of large abdominal wall defects, specifically in general and plastic surgery applications, as a non-absorbable surgical mesh device.

• How is the Avance Abdominal Dressing Kit supplied and is it sterile?

  The device is supplied as a kit, and while the data does not explicitly state sterility, it is intended for use in clinical settings, implying it is provided in a sterile condition for surgical use.

• Is the Avance Abdominal Dressing Kit reusable or single-use?

  The Avance Abdominal Dressing Kit is a non-absorbable surgical mesh intended for implantation, which indicates it is a single-use device designed for permanent placement and not meant to be removed or reused.

• What regulatory pathway was used for the Avance Abdominal Dressing Kit?

  The Avance Abdominal Dressing Kit received FDA 510(k) clearance under submission number K161939, classified as a Class II medical device under regulation 878.3300, and was found substantially equivalent to a predicate device.