Cleared Traditional

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

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

About This 510(k) Submission

K211021 is an FDA 510(k) clearance for the Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Micro-Tech (Nanjing) Co., Ltd. (Narijing, CN). The FDA issued a Cleared decision on May 6, 2022, 396 days after receiving the submission on April 5, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K211021 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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