DeviceClearance

Product code GCA— Gastroenterology, Urology

ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR

Classification name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Total cleared
26
First cleared
Most recent

Market context for product code GCA

FDA has cleared 26 devices under product code GCA between 1977 and 2026, filed by 18 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 GCA

Recent clearances under product code GCA

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