Cleared Traditional

K980653 - PERFLEX STAINLESS STEEL STENT AND DELIV...

K980653 is an FDA 510(k) clearance for PERFLEX STAINLESS STEEL STENT AND DELIV..., manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K980653 · Cordis Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
118d
Days
Class 2
Risk

K980653 is an FDA 510(k) clearance for the PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on June 9, 1998 after a review of 118 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 Cordis Corp. devices

FDA 510(k) Submission Details - K980653

510(k) Number K980653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date June 09, 1998
Days to Decision 118 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
12d faster than avg
Panel avg: 130d · This submission: 118d
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 317
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K980653.
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · Cordis Corp. · Dec 1998
FLEXIMA
K982508 · Boston Scientific Corp · Oct 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · Boston Scientific Scimed, Inc. · Sep 1998
MANAN VS ACCESS NEEDLE/SET
K980372 · Medical Device Technologies, Inc. · Apr 1998
MANAN BILIARY DRAINAGE CATHETER
K980191 · Medical Device Technologies, Inc. · Feb 1998
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · Medical Device Technologies, Inc. · Jan 1998