Cleared Traditional

K930623 - MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH

K930623 is an FDA 510(k) clearance for MICROVASIVE INSURG BILIARY BALLOON DILA..., 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 597-day FDA review.

K930623 · Boston Scientific Corp · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
597d
Days
Class 2
Risk

K930623 is an FDA 510(k) clearance for the MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH. 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 September 28, 1994 after a review of 597 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 - K930623

510(k) Number K930623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date September 28, 1994
Days to Decision 597 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
466d slower than avg
Panel avg: 131d · This submission: 597d
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 K930623.
BILIARY STENT
K943143 · Menlo Care, Inc. · Feb 1995
BALLOON DILATION CATHETER
K935094 · Wilson-Cook Medical, Inc. · Jan 1995
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
K925406 · Schneider Intl., Ltd. · Jan 1995
AMERICAN CATHETER E.R.C.P. CANNULA
K940370 · Intl. Medical, Inc. · Aug 1994
ELIMINATOR BALLOON DILATOR
K940965 · C.R. Bard, Inc. · May 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994