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FDA 510(k)

Endoscopic Injection Needles

K-Number: K240675 · 2024-10-04

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2024-10-04
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Injection Needles is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2024-10-04 under approval number K240675. 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 Endoscopic Injection Needles?

Endoscopic Injection Needles is a medical device that received FDA 510(k) clearance on 2024-10-04. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K240675.

When was Endoscopic Injection Needles approved by the FDA?

Endoscopic Injection Needles received FDA 510(k) clearance on 2024-10-04, under approval number K240675.

What company makes Endoscopic Injection Needles?

Endoscopic Injection Needles is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Endoscopic Injection Needles?

The FDA product code for Endoscopic Injection Needles is FBK.

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Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix 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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