DeviceClearance

Product code GBZ— General, Plastic Surgery

ANGIOLAPCATH CHOLANGIOGRAPHY KIT

Classification name
Catheter, Cholangiography
Device class
Class 1
Regulation
21 CFR 878.4200
Advisory panel
General, Plastic Surgery
Total cleared
24
First cleared
Most recent

Market context for product code GBZ

FDA has cleared 24 devices under product code GBZ between 1978 and 1997, filed by 21 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 GBZ

Adverse events under product code GBZ

product code GBZ
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 GBZ

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