Cleared Traditional

K211021 - Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible (FDA 510(k) Clearance)

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

K211021 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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May 2022
Decision
396d
Days
Class 2
Risk

K211021 is an FDA 510(k) clearance for the Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-w.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Narijing, CN). The FDA issued a Cleared decision on May 6, 2022 after a review of 396 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K211021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2021
Decision Date May 06, 2022
Days to Decision 396 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
266d slower than avg
Panel avg: 130d · This submission: 396d
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 473
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K211021.
Dilation Balloon Catheter
K253832 · Mirco-Tech (Nanjing) Co., Ltd. · Apr 2026
Endoflux™ Biliary & Pancreatic Stent Sets
K251658 · Medi-Globe GmbH · Apr 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987 · GIE Medical · Mar 2026
Single use stone retrieval balloons
K253132 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2026
Niti-S Biliary Stent
K251123 · Taewoong Medical Co., Ltd. · Dec 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · Bioteque Corporation · Dec 2025