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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 a medical device manufactured by Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2024-08-27 under approval 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. It is manufactured by Laborie Medical Technologies, Corp.. The 510(k) number is K241523.

When was injeTAK Adjustable Tip Needle (DIS199; DIS201) approved by the FDA?

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

What company makes injeTAK Adjustable Tip Needle (DIS199; DIS201)?

injeTAK Adjustable Tip Needle (DIS199; DIS201) is manufactured by Laborie Medical Technologies, Corp..

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.

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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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