510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150040Unknown

WallFlex Biliary RX Fully Covered Stent System RMV

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

DEN150040 is the FDA 510(k) clearance record for WallFlex Biliary RX Fully Covered Stent System RMV, a class II device, cleared for Boston Scientific on under FDA product code PNB (Biliary Stent System For Benign Strictures). FDA's definition for product code PNB reads: "A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a...". FDA records list 1,110 510(k) clearances for Boston Scientific, from to . As of , FDA records show no recalls naming DEN150040.

Clearance record

Decision date
Received
(280 days to decision)
Product code
PNB Biliary Stent System For Benign Strictures
Regulation
21 CFR 876.5011
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific 100 Boston Scientific Way, Marlboro MA
Third party review
No

Clearances, product code PNB

Trailing 12 months

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

FDA records show no clearances under product code PNB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNB, 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