DeviceClearance

Product code GDM— General, Plastic Surgery

BIOACCESS MARROW HARVEST SYSTEM

Classification name
Needle, Aspiration And Injection, Reusable
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
48
First cleared
Most recent

Market context for product code GDM

FDA has cleared 48 devices under product code GDM between 1977 and 2007, filed by 37 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 GDM

Adverse events under product code GDM

product code GDM
Death
2
Total
2

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 GDM

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