DeviceClearance

Product code GCX— General Hospital

CONTAIN(TM)

Classification name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class
Class 2
Regulation
21 CFR 880.6740
Advisory panel
General Hospital
Total cleared
87
First cleared
Most recent

Market context for product code GCX

FDA has cleared 87 devices under product code GCX between 1976 and 2004, filed by 62 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GCX

Adverse events under product code GCX

product code GCX
Death
9
Malfunction
592
Other
2
Total
603

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 GCX

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