Cleared Traditional

K993904 - INTRASTENT DOUBLESTRUT LD

K993904 is an FDA 510(k) clearance for INTRASTENT DOUBLESTRUT LD, manufactured by Intratherapeutics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K993904 · Intratherapeutics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
76d
Days
Class 2
Risk

K993904 is an FDA 510(k) clearance for the INTRASTENT DOUBLESTRUT LD. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Intratherapeutics, Inc. (Saint Paul, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 76 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 Intratherapeutics, Inc. devices

FDA 510(k) Submission Details - K993904

510(k) Number K993904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 17, 1999
Decision Date February 01, 2000
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K993904.
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564 · Cordis Corp. · Mar 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · Boston Scientific Corp · Mar 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550 · Advanced Cardiovascular Systems, Inc. · Mar 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
K994156 · Cordis Corp. · Jan 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392 · C.R. Bard, Inc. · Jan 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
K993892 · C.R. Bard, Inc. · Jan 2000