510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K915129Unknown

Catheter with Introducer and Syringes

Utah Pioneer Medical, Inc., Orem UT / Traditional, Unknown
FDA source (opens on fda.gov)

K915129 is the FDA 510(k) clearance record for CATHETER WITH INTRODUCER AND SYRINGES, a class II device, cleared for Utah Pioneer Medical, Inc. on under FDA product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection). FDA records list 2 510(k) clearances for Utah Pioneer Medical, Inc., from to . As of , FDA records show no recalls naming K915129.

Clearance record

Decision date
Received
(147 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
Utah Pioneer Medical, Inc. P.O.Box 1163, Orem UT
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 October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GCA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260