Cleared Traditional

PBN DILATORS (K990808) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990808 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
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Nov 1999
Decision
260d
Days
Class 2
Risk

K990808 is an FDA 510(k) clearance for the PBN DILATORS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 260 days - an extended review 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: 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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K990808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date November 26, 1999
Days to Decision 260 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
130d slower than avg
Panel avg: 130d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 188
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K990808.
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
K993892 · C.R. Bard, Inc. · Jan 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · Cordis Corp. · Dec 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K993646 · Cordis Corp. · Nov 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · Cordis Corp. · Oct 1999
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