MCA — Tape, Surgical, Internal Class II

FDA Device Classification

FDA product code MCA covers "Tape, Surgical, Internal", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
MCA
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K900195w. l. gore and associatesMODIFIED GORE-TEX SURGICAL TAPEMarch 13, 1990