DeviceClearance

Product code GBX— General, Plastic Surgery

ACI SILICATH THORACIC CATHETER

Classification name
Catheter, Irrigation
Device class
Class 1
Regulation
21 CFR 878.4200
Advisory panel
General, Plastic Surgery
Total cleared
77
First cleared
Most recent

Market context for product code GBX

FDA has cleared 77 devices under product code GBX between 1977 and 2014, filed by 58 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 GBX

Adverse events under product code GBX

product code GBX
Death
16
Injury
583
Malfunction
3,578
Other
1
Total
4,178

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 GBX

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