DeviceClearance

Product code GDX— General, Plastic Surgery

SCALPEL

Classification name
Scalpel, One-Piece
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
26
First cleared
Most recent

Market context for product code GDX

FDA has cleared 26 devices under product code GDX between 1978 and 1992, filed by 26 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 GDX

Recent clearances under product code GDX

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