DeviceClearance

Product code FSM— General, Plastic Surgery

CASF STERILIZATION TRAY

Classification name
Tray, Surgical, Instrument
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
76
First cleared
Most recent

Market context for product code FSM

FDA has cleared 76 devices under product code FSM between 1976 and 1997, filed by 55 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code FSM

Adverse events under product code FSM

product code FSM
Malfunction
1,289
Total
1,289

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FSM

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