Cleared Traditional

K200103 - BIOTEQ Drainage Catheter Set (One Step ...

K200103 is an FDA 510(k) clearance for BIOTEQ Drainage Catheter Set (One Step ..., manufactured by Bioteque Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K200103 · Bioteque Corporation · Gastroenterology & Urology device
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Oct 2020
Decision
266d
Days
Class 2
Risk

K200103 is an FDA 510(k) clearance for the BIOTEQ Drainage Catheter Set (One Step Type). Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Bioteque Corporation (Taipei City, TW). The FDA issued a Cleared decision on October 9, 2020 after a review of 266 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 Bioteque Corporation devices

FDA 510(k) Submission Details - K200103

510(k) Number K200103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2020
Decision Date October 09, 2020
Days to Decision 266 days
Submission Type Traditional
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
136d slower than avg
Panel avg: 130d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K200103.
BIOTEQ Drainage Catheter BT-PDS-series
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HANAROSTENT Benefit Biliary (NNN)
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Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · Boston Scientific Corporation · Dec 2020
EndoGI S-Path Biliary Stent System
K202477 · Endo GI Medical · Sep 2020
EndoGI Biliary Stent System
K193600 · Endogi Medical, Ltd. · Jun 2020
ConvertX Biliary Stent System
K181669 · Brightwater Medical · Mar 2019