Cleared Traditional

K990854 - INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE

K990854 is an FDA 510(k) clearance for INNERDYNE RADIALLY EXPANDING DILATION, manufactured by Innerdyne, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K990854 · Innerdyne, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
140d
Days
Class 2
Risk

K990854 is an FDA 510(k) clearance for the INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Innerdyne, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 2, 1999 after a review of 140 days - within the typical 510(k) review window.

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 Innerdyne, Inc. devices

FDA 510(k) Submission Details - K990854

510(k) Number K990854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date August 02, 1999
Days to Decision 140 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
9d slower than avg
Panel avg: 131d · This submission: 140d
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 412
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K990854.
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
K991674 · Cordis Corp. · Aug 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028 · Cordis Corp. · Aug 1999
INTRASTENT
K991929 · Intratherapeutics, Inc. · Aug 1999
MEDTRONIC AVE BRIDGE STENT
K992318 · Medtronic Ave, Inc. · Aug 1999
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
K991533 · Peripheral Ave · Jul 1999
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
K991793 · AngioDynamics, Inc. · Jun 1999