510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161011Substantially Equivalent

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive

Adhezion Biomedical, LLC, Wyomissing PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161011 is the FDA 510(k) clearance record for SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive, a class II device, cleared for Adhezion Biomedical, LLC on under FDA product code MPN (Tissue Adhesive For The Topical Approximation Of Skin). FDA's definition for product code MPN reads: "Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k)". FDA records list 12 510(k) clearances for Adhezion Biomedical, LLC, from to . As of , FDA records show no recalls naming K161011.

Clearance record

Decision date
Received
(211 days to decision)
Product code
MPN Tissue Adhesive For The Topical Approximation Of Skin
Regulation
21 CFR 878.4010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Adhezion Biomedical, LLC One Meridian Blvd., Suite 1b02, Wyomissing PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MPN

Trailing 12 months

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

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