510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN230019Unknown

AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)

Boston Scientific Corporation, Marlboro MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230019 is the FDA 510(k) clearance record for AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent), a class II device, cleared for Boston Scientific Corporation on under FDA product code QXH (Gallbladder Drainage Stent And Delivery System). FDA's definition for product code QXH reads: "A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming DEN230019.

Clearance record

Decision date
Received
(144 days to decision)
Product code
QXH Gallbladder Drainage Stent And Delivery System
Regulation
21 CFR 876.5016
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
Third party review
No

Clearances, product code QXH

Trailing 12 months

FDA records hold no clearances under product code QXH in the trailing twelve months.

FDA records show no clearances under product code QXH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260