510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161939Substantially Equivalent

Avance Abdominal Dressing Kit

Molnlycke Health Care, US LLC, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161939 is the FDA 510(k) clearance record for Avance Abdominal Dressing Kit, a class II device, cleared for Molnlycke Health Care Us, LLC on under FDA product code OXJ (Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects). FDA's definition for product code OXJ reads: "For reinforcement of soft tissue where weakness exists in abdominal wall defects". FDA records list 27 510(k) clearances for Molnlycke Health Care Us, LLC, from to . As of , FDA records show no recalls naming K161939.

Clearance record

Decision date
Received
(126 days to decision)
Product code
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Molnlycke Health Care Us, LLC 5550 Peachtree Pkwy., Suite 500, Norcross GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXJ

Trailing 12 months

FDA records hold no clearances under product code OXJ in the trailing twelve months.

FDA records show no clearances under product code OXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260