510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063733Substantially Equivalent

Resolve Biliary Drainage Catheter

Merit Medical Systems, Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063733 is the FDA 510(k) clearance record for RESOLVE BILIARY DRAINAGE CATHETER, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show 4 recalls naming K063733.

Clearance record

Decision date
Received
(331 days to decision)
Product code
FGE Stents, Drains And Dilators For The Biliary Ducts
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Merit Medical Systems, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGE

Trailing 12 months
10 clearances under product code FGE in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FGE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20262
April 20262
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260