Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K211021 · 2022-05-06

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2022-05-06
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under approval number K211021. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211021.

When was Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible approved by the FDA?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible received FDA 510(k) clearance on 2022-05-06, under approval number K211021.

What company makes Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

The FDA product code for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is FGE.

Related Clinical Trials

NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING

Other Devices by Micro-Tech (Nanjing) Co., Ltd.

K162466LuminScan (TM) Imaging System K160625Disposable Hot Biopsy Forceps K152802Grasping Forceps K172309Endoscopic Ultrasound Aspiration Needle K162226Reliant Multistage Dilatation Balloon Catheter K161463SureClip(TM) Repositionable Hemostasis Clip

View all 37 devices →

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑