Cleared Traditional

K211934 - APDL Drainage Catheter System

K211934 is the FDA 510(k) clearance for APDL Drainage Catheter System by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 506-day FDA review.

K211934 · Boston Scientific Corporation · Gastroenterology & Urology device
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Nov 2022
Decision
506d
Days
Class 2
Risk

K211934 is an FDA 510(k) clearance for the APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima.... Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 506 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K211934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 22, 2021
Decision Date November 10, 2022
Days to Decision 506 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 130d · This submission: 506d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAD Stent, Ureteral

All 74
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K211934.
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RELIEF Ureteral Stent Kit
K213444 · Ureteral Stent Company · Mar 2022
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