Cleared Traditional

K900205 - DRAINAGE CATHETERS W/A DISSOLVABLE TIP

K900205 is the FDA 510(k) clearance for DRAINAGE CATHETERS W/A DISSOLVABLE TIP by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
451d slower than avg
Panel avg: 130d · This submission: 581d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K900205.
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
K913073 · Biosearch Medical Products, Inc. · Oct 1991
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
K913841 · Endovations · Oct 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · Baxter Healthcare Corp · Sep 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991
BALLOON CATHETERS
K904669 · Olympus Corp. · Mar 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · Baxter Healthcare Corp · Feb 1991