Cleared Traditional

K900205 - DRAINAGE CATHETERS W/A DISSOLVABLE TIP

K900205 is an FDA 510(k) clearance for DRAINAGE CATHETERS W/A DISSOLVABLE TIP, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 581-day FDA review.

K900205 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 1991
Decision
581d
Days
Class 2
Risk

K900205 is an FDA 510(k) clearance for the DRAINAGE CATHETERS W/A DISSOLVABLE TIP. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on August 20, 1991 after a review of 581 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Corp devices

FDA 510(k) Submission Details - K900205

510(k) Number K900205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date August 20, 1991
Days to Decision 581 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
450d slower than avg
Panel avg: 131d · This submission: 581d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K900205.
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K912971 · Interventional Therapeutics Corp. · Sep 1991
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
K910671 · Solos Endoscopy, Inc. · May 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991
AVD INTIMAX CHOLANGIOGRAPHY CATHETER
K910493 · Applied Vascular Devices, Inc. · Mar 1991