Product code HAB— General, Plastic Surgery

POWERPRO BATTERY SYSTEM

Classification name
Saw, Powered, And Accessories
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

Market context for product code HAB

FDA has cleared 2 devices under product code HAB between 1994 and 2001, filed by 2 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

Top applicants under product code HAB

Adverse events under product code HAB

product code HAB
Injury
283
Malfunction
5,362
Total
5,645

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 HAB

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