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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 the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) 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. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K232442.

When did Disposable Endoscope Injection Needles receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Endoscope Injection Needles?

The FDA 510(k) record lists Zhejiang Soudon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Zhejiang Soudon Medical Technology Co., Ltd. as applicant

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Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

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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