510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K212246Substantially Equivalent

Exofin Precision Pen

Chemence Medical Inc., Alpharetta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212246 is the FDA 510(k) clearance record for Exofin Precision Pen, a class II device, cleared for Chemence Medical, Inc. 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 6 510(k) clearances for Chemence Medical, Inc., from to . As of , FDA records show no recalls naming K212246.

Clearance record

Decision date
Received
(52 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
Chemence Medical, Inc. 200 Technology Dr., Alpharetta GA
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