← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
MPN — Tissue Adhesive For The Topical Approximation Of Skin
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
DEVICE CLASS
Class II
REGULATION
21 CFR 878.4010
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K243990Optmed, Inc. · 510k2025-09-19
K250950Okapi Medical, LLC Dba Resivant Medical · 510k2025-08-04
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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