DeviceClearance

Product code KCY— General, Plastic Surgery

ACCUFLATE

Classification name
Tourniquet, Pneumatic
Device class
Class 1
Regulation
21 CFR 878.5910
Advisory panel
General, Plastic Surgery
Total cleared
34
First cleared
Most recent

Market context for product code KCY

FDA has cleared 34 devices under product code KCY between 1978 and 2021, filed by 25 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 KCY

Adverse events under product code KCY

product code KCY
Malfunction
868
Total
868

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 KCY

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