510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944290Substantially Equivalent

Catheters, Biliary Catheters, Urological

Boston Scientific Corporation, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944290 is the FDA 510(k) clearance record for CATHETERS, BILIARY CATHETERS, UROLOGICAL, a class II device, cleared for Boston Scientific Corp on under FDA product code FFA (Tube, Drainage, Suprapubic). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show 5 recalls naming K944290.

Clearance record

Decision date
Received
(97 days to decision)
Product code
FFA Tube, Drainage, Suprapubic
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp 780 Brookside Dr., Spencer IN
510(k) summary
Summary
Third party review
No

Clearances, product code FFA

Trailing 12 months

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

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