MCA

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tape, Surgical, Internal

Device class

Class II (moderate risk)

Regulation

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Flags

Implant

Adverse events (MAUDE)

1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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