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FDA 510(k)

MySegmenter (v2.0.0)

K-Number: K242647 · 2025-04-16

ApplicantMysegmenter Technologies, Inc.
Decision Date2025-04-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MySegmenter (v2.0.0) is a medical device manufactured by Mysegmenter Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-16 under approval number K242647. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySegmenter (v2.0.0)?

MySegmenter (v2.0.0) is a medical device that received FDA 510(k) clearance on 2025-04-16. It is manufactured by Mysegmenter Technologies, Inc.. The 510(k) number is K242647.

When was MySegmenter (v2.0.0) approved by the FDA?

MySegmenter (v2.0.0) received FDA 510(k) clearance on 2025-04-16, under approval number K242647.

What company makes MySegmenter (v2.0.0)?

MySegmenter (v2.0.0) is manufactured by Mysegmenter Technologies, Inc..

What is the FDA product code for MySegmenter (v2.0.0)?

The FDA product code for MySegmenter (v2.0.0) is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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