Cleared Special

K000550 - OTW MEGALINK SDS BILIARY STENT SYSTEM

K000550 is the FDA 510(k) clearance for OTW MEGALINK SDS BILIARY STENT SYSTEM by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 28-day FDA review.

K000550 · Advanced Cardiovascular Systems, Inc. · Gastroenterology & Urology device
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Mar 2000
Decision
28d
Days
Class 2
Risk

K000550 is an FDA 510(k) clearance for the OTW MEGALINK SDS BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 17, 2000 after a review of 28 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K000550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 18, 2000
Decision Date March 17, 2000
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 305
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K000550.
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K000793 · Guidant Corp. · Apr 2000
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
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