510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211934Unknown

APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

Boston Scientific Corporation, Maple Grove MN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211934 is the FDA 510(k) clearance record for APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg, a class II device, cleared for Boston Scientific Corporation on under FDA product code FAD (Stent, Ureteral). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show 5 recalls naming K211934.

Clearance record

Decision date
Received
(506 days to decision)
Product code
FAD Stent, Ureteral
Regulation
21 CFR 876.4620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corporation One Scimed Pl., Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FAD

Trailing 12 months
2 clearances under product code FAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260