510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K081635Substantially Equivalent

Integra Meshed Bilayer Wound Matrix

Integra LifeSciences Corporation, Planisboro NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081635 is the FDA 510(k) clearance record for INTEGRA MESHED BILAYER WOUND MATRIX, cleared for Integra Lifesciences Corp. on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list 94 510(k) clearances for Integra Lifesciences Corp., from to . As of , FDA records show no recalls naming K081635.

Clearance record

Decision date
Received
(176 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Integra Lifesciences Corp. 311 Enterprise Dr., Planisboro NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGN

Trailing 12 months
18 clearances under product code KGN in the twelve months to November 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code KGN, trailing twelve months
MonthClearances
December 20253
January 20261
February 20262
March 20261
April 20260
May 20261
June 20265
July 20261
August 20261
September 20261
October 20262
November 20260