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FDA 510(k)

injeTAK Adjustable Tip Needle (DIS199; DIS201)

K-Number: K241523 · 2024-08-27

ApplicantLaborie Medical Technologies, Corp.
Decision Date2024-08-27
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

injeTAK Adjustable Tip Needle (DIS199; DIS201) is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K241523. 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 injeTAK Adjustable Tip Needle (DIS199; DIS201)?

injeTAK Adjustable Tip Needle (DIS199; DIS201) is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Laborie Medical Technologies, Corp.. The 510(k) number is K241523.

When did injeTAK Adjustable Tip Needle (DIS199; DIS201) receive FDA 510(k) clearance?

injeTAK Adjustable Tip Needle (DIS199; DIS201) received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241523.

Who is the listed applicant for injeTAK Adjustable Tip Needle (DIS199; DIS201)?

The FDA 510(k) record lists Laborie Medical Technologies, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for injeTAK Adjustable Tip Needle (DIS199; DIS201)?

The FDA product code for injeTAK Adjustable Tip Needle (DIS199; DIS201) is FBK.

Other records listing Laborie Medical Technologies, Corp. 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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