DeviceClearance

Product code MPN— General, Plastic Surgery

SURGISEAL TOPICAL SKIN ADHESIVE

Classification name
Tissue Adhesive For The Topical Approximation Of Skin
Device class
Class 2
Regulation
21 CFR 878.4010
Advisory panel
General, Plastic Surgery
Total cleared
36
First cleared
Most recent

FDA classification definition

“Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).”

— U.S. Food and Drug Administration, device classification record for product code MPN under 21 CFR 878.4010, via openFDA

Market context for product code MPN

FDA has cleared 36 devices under product code MPN between 2008 and 2025, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MPN

Adverse events under product code MPN

product code MPN
Injury
856
Other
1
Total
857

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MPN

Data sourced from openFDA. This site is unofficial and independent of the FDA.