Product code MTC— General Hospital

Instant 20s Indicator

Classification name
Indicator, Chemical, Enzymatic, Sterilization Process
Device class
Class 2
Regulation
21 CFR 880.2800
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

Market context for product code MTC

FDA has cleared 2 devices under product code MTC between 1997 and 2021, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code MTC

Recent clearances under product code MTC

Data sourced from openFDA. This site is unofficial and independent of the FDA.