Cleared Special

K993646 - S.M.A.R.T. .018 NITINOL STENT TRANSHEPA...

K993646 is an FDA 510(k) clearance for S.M.A.R.T. .018 NITINOL STENT TRANSHEPA..., manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 30-day FDA review.

K993646 · Cordis Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
30d
Days
Class 2
Risk

K993646 is an FDA 510(k) clearance for the S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on November 28, 1999 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K993646

510(k) Number K993646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 29, 1999
Decision Date November 28, 1999
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K993646.
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
K993892 · C.R. Bard, Inc. · Jan 2000
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232 · Boston Scientific Scimed, Inc. · Dec 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · Cordis Corp. · Dec 1999
PBN DILATORS
K990808 · Medical Device Technologies, Inc. · Nov 1999
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
K993588 · Guidant Corp. · Nov 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · Cordis Corp. · Oct 1999