Cleared Traditional

K924608 - HYDROGEL COATED PERCUFLEX DRAINAGE CATH...

K924608 is the FDA 510(k) clearance for HYDROGEL COATED PERCUFLEX DRAINAGE CATH... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 502-day FDA review.

K924608 · Boston Scientific Corp · Gastroenterology & Urology device
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Jan 1994
Decision
502d
Days
Class 2
Risk

K924608 is an FDA 510(k) clearance for the HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS. 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 January 26, 1994 after a review of 502 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 K924608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1992
Decision Date January 26, 1994
Days to Decision 502 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
372d slower than avg
Panel avg: 130d · This submission: 502d
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 K924608.
BALLOON DILATION CATHETER
K935094 · Wilson-Cook Medical, Inc. · Jan 1995
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994
ELIMINATOR BALLOON DILATOR
K940965 · C.R. Bard, Inc. · May 1994
URESIL BILLIARY CATHETER
K923096 · Uresil Corp. · Jul 1993
ERCP CANNULA
K924107 · United States Endoscopy Group, Inc. · Dec 1992
BARD BILIARY BALLOON DILATORS
K920361 · C.R. Bard, Inc. · Nov 1992