Cleared Traditional

INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. (K934377) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934377 · Interventional Thermodynamics, Inc. · Gastroenterology & Urology device
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Feb 1994
Decision
151d
Days
Class 2
Risk

K934377 is an FDA 510(k) clearance for the INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Interventional Thermodynamics, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 151 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Interventional Thermodynamics, Inc. devices

Submission Details

510(k) Number K934377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date February 07, 1994
Days to Decision 151 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 130d · This submission: 151d
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 181
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K934377.
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994
ELIMINATOR BALLOON DILATOR
K940965 · C.R. Bard, Inc. · May 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994
BARD BILIARY BALLOON DILATORS
K920361 · C.R. Bard, Inc. · Nov 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · Cook, Inc. · Jul 1992