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

System, Skin Closure

21 CFR 878.4320 / General, Plastic Surgery
FDA source (opens on fda.gov)

MKY is the FDA product code for System, Skin Closure, a class I device type, regulated under 21 CFR 878.4320. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MKY
Device name
System, Skin Closure
Regulation
21 CFR 878.4320
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code MKY

By decision year
6 clearances under product code MKY with a decision year between 1994 and 2001, 1994 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MKY by decision year
YearClearances
19942
19972
19981
20011

Applicants with the most clearances

Product code MKY
Applicants holding the most 510(k) clearances under product code MKY
ApplicantClearances
Progressive Surgical Products, Inc.3
Life Medical Sciences, Inc.1
Phoenix Biomedical Corp.1
Wisebands, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order