Cleared Traditional

K033862 - BIOTEQ PIGTAIL DRAINAGE CATHETER SET (O...

K033862 is the FDA 510(k) clearance for BIOTEQ PIGTAIL DRAINAGE CATHETER SET (O... by Bioteque Corp.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K033862 · Bioteque Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
430d
Days
Class 2
Risk

K033862 is an FDA 510(k) clearance for the BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY S.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Bioteque Corp. (Taipei, TW). The FDA issued a Cleared decision on February 14, 2005 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Bioteque Corp. devices

Submission Details

510(k) Number K033862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2003
Decision Date February 14, 2005
Days to Decision 430 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
300d slower than avg
Panel avg: 130d · This submission: 430d
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 263
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K033862.
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · Cook, Inc. · Mar 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
K050627 · Edwards Lifesciences, LLC · Mar 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · Abbott Laboratories · Feb 2005
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481 · Cook, Inc. · Dec 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
K042985 · Edwards Lifesciences, LLC · Dec 2004
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K042969 · Cordis Corp. · Nov 2004