510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K915506Unknown

Laparoscopic Cholangiogram Catheter Kit

United States Endoscopy Group, Inc., Mentor OH / Traditional, Unknown
FDA source (opens on fda.gov)

K915506 is the FDA 510(k) clearance record for LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection). FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K915506.

Clearance record

Decision date
Received
(88 days to decision)
Product code
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 9300 Progress Pkwy., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code GCA

Trailing 12 months
1 clearance under product code GCA in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GCA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260