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FDA 510(k)

Disposable Endoscopic Injection Needles

K-Number: K252021 · 2025-12-02

ApplicantChangzhou New Med Micro-Medtech Co., Ltd.
Decision Date2025-12-02
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Injection Needles is a medical device manufactured by Changzhou New Med Micro-Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-02 under approval number K252021. 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 Endoscopic Injection Needles?

Disposable Endoscopic Injection Needles is a medical device that received FDA 510(k) clearance on 2025-12-02. It is manufactured by Changzhou New Med Micro-Medtech Co., Ltd.. The 510(k) number is K252021.

When was Disposable Endoscopic Injection Needles approved by the FDA?

Disposable Endoscopic Injection Needles received FDA 510(k) clearance on 2025-12-02, under approval number K252021.

What company makes Disposable Endoscopic Injection Needles?

Disposable Endoscopic Injection Needles is manufactured by Changzhou New Med Micro-Medtech Co., Ltd..

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

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

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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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