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FDA 510(k)

Disposable Endoscope Injection Needles

K-Number: K232442 · 2023-11-09

ApplicantZhejiang Soudon Medical Technology Co., Ltd.
Decision Date2023-11-09
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Injection Needles is a medical device manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under approval number K232442. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscope Injection Needles?

Disposable Endoscope Injection Needles is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K232442.

When was Disposable Endoscope Injection Needles approved by the FDA?

Disposable Endoscope Injection Needles received FDA 510(k) clearance on 2023-11-09, under approval number K232442.

What company makes Disposable Endoscope Injection Needles?

Disposable Endoscope Injection Needles is manufactured by Zhejiang Soudon Medical Technology Co., Ltd..

What is the FDA product code for Disposable Endoscope Injection Needles?

The FDA product code for Disposable Endoscope Injection Needles is FBK.

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Other Devices by Zhejiang Soudon Medical Technology Co., Ltd.

K232476Disposable Sphincterotome K232450Disposable Hemostatic Clips K253013Disposable Stone Retrieval Balloon Catheter K253056Disposable Stone Extraction Basket

Related Devices (Code: FBK)

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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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