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

Tissue Adhesive For The Topical Approximation Of Skin

21 CFR 878.4010 / General, Plastic Surgery
FDA source (opens on fda.gov)

MPN is the FDA product code for Tissue Adhesive For The Topical Approximation Of Skin, a class II device type, regulated under 21 CFR 878.4010. FDA's definition for this code reads: "Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k)". As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MPN
Device name
Tissue Adhesive For The Topical Approximation Of Skin
FDA definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Regulation
21 CFR 878.4010
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
2

Clearances, product code MPN

By decision year
36 clearances under product code MPN with a decision year between 2008 and 2025, 2013 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MPN by decision year
YearClearances
20081
20091
20103
20112
20122
20136
20144
20154
20165
20202
20211
20243
20252

Applicants with the most clearances

Product code MPN
Applicants holding the most 510(k) clearances under product code MPN
ApplicantClearances
Adhezion Biomedical, LLC9
Advanced Medical Solutions (Plymouth), Ltd.4
Medlogic Global Limited4
Aesculap Inc3
Chemence Medical Inc.3
Chemence Medical Products, Inc.2
Ethicon, Inc2
Okapi Medical, LLC dba Resivant Medical2
OptMed, Inc2
Advanced Medical Solutions Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order