510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003229Substantially Equivalent

Biopatch Antimicrobial Dressing

Integra LifeSciences Corporation, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003229 is the FDA 510(k) clearance record for BIOPATCH ANTIMICROBIAL DRESSING, cleared for Integra Lifesciences Corp. on under FDA product code SEL (Securement Wound Dressing For Reduction Of Infection). FDA's definition for product code SEL reads: "These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used...". FDA records list 94 510(k) clearances for Integra Lifesciences Corp., from to . As of , FDA records show no recalls naming K003229.

Clearance record

Decision date
Received
(381 days to decision)
Product code
SEL Securement Wound Dressing For Reduction Of Infection
Device class
Unclassified
Review panel
Unknown
Applicant
Integra Lifesciences Corp. Rte 22, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code SEL

Trailing 12 months

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

FDA records show no clearances under product code SEL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEL, 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