Cleared Traditional

K033210 - BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET

K033210 is the FDA 510(k) clearance for BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET by Bioteque Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K033210 · Bioteque Corp. · Gastroenterology & Urology device
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Dec 2004
Decision
454d
Days
Class 2
Risk

K033210 is an FDA 510(k) clearance for the BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Bioteque Corp. (Flagstaff, US). The FDA issued a Cleared decision on December 30, 2004 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 K033210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2003
Decision Date December 30, 2004
Days to Decision 454 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
324d slower than avg
Panel avg: 130d · This submission: 454d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 73
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