Cleared Traditional

K924451 - INTHERM SINGLE-STICK RADIALLY EXPANDING...

K924451 is the FDA 510(k) clearance for INTHERM SINGLE-STICK RADIALLY EXPANDING... by Interventional Therapeutics Corp.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K924451 · Interventional Therapeutics Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
52d
Days
Class 2
Risk

K924451 is an FDA 510(k) clearance for the INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (Mountain View, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interventional Therapeutics Corp. devices

Submission Details

510(k) Number K924451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date October 23, 1992
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
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 245
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K924451.
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994
ERCP CANNULA
K924107 · United States Endoscopy Group, Inc. · Dec 1992
BARD BILIARY BALLOON DILATORS
K920361 · C.R. Bard, Inc. · Nov 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · Cook, Inc. · Jul 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · Cook, Inc. · May 1992
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
K913073 · Biosearch Medical Products, Inc. · Oct 1991