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

Tape, Surgical, Internal

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

MCA is the FDA product code for Tape, Surgical, Internal, a class II device type, regulated under 21 CFR 878.3300. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MCA
Device name
Tape, Surgical, Internal
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code MCA

By decision year
1 clearance under product code MCA with a decision year between 1990 and 1990, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MCA by decision year
YearClearances
19901

Applicants with the most clearances

Product code MCA
Applicants holding the most 510(k) clearances under product code MCA
ApplicantClearances
W. L. Gore & Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code