MTC · Class II · 21 CFR 880.2800

FDA Product Code MTC: Indicator, Chemical, Enzymatic, Sterilization Process

Leading manufacturers include True Indicating, LLC.

2
Total
2
Cleared
372d
Avg days
1997
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Indicator, Chemical, Enzymatic, Sterilization Process Devices (Product Code MTC)

2 devices
1–2 of 2

About Product Code MTC - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code MTC since 1997, with 2 receiving FDA clearance (average review time: 372 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

MTC devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →