Product code MCA— General, Plastic Surgery
MODIFIED GORE-TEX SURGICAL TAPE
- Classification name
- Tape, Surgical, Internal
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code MCA
FDA has cleared device under product code MCA, all in 1990, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code MCA
Recent clearances under product code MCA
Data sourced from openFDA. This site is unofficial and independent of the FDA.