Cleared Traditional

K913932 - PERCUTANEOUS DILATOR WITH SHEATH

K913932 is an FDA 510(k) clearance for PERCUTANEOUS DILATOR WITH SHEATH, manufactured by Interventional Therapeutics Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K913932 · Interventional Therapeutics Corp. · Gastroenterology & Urology device
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Nov 1991
Decision
80d
Days
Class 2
Risk

K913932 is an FDA 510(k) clearance for the PERCUTANEOUS DILATOR WITH SHEATH. 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 November 22, 1991 after a review of 80 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

FDA 510(k) Submission Details - K913932

510(k) Number K913932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date November 22, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 131d · This submission: 80d
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 364
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K913932.
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
K913986 · Medical Dynamics, Inc. · Jan 1992
WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K914881 · Wiltek Medical, Inc. · Jan 1992
WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
K914882 · Wiltek Medical, Inc. · Jan 1992
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