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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 the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) 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. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211021.

When did Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible receive FDA 510(k) clearance?

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

Who is the listed applicant for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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