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FDA 510(k)

Hexoskin Medical System (7100-00016)

K-Number: K243981 · 2025-11-18

ApplicantCarre Technologies, Inc.
Decision Date2025-11-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hexoskin Medical System (7100-00016) is the device name listed in this FDA 510(k) record. The listed applicant is Carre Technologies, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K243981. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hexoskin Medical System (7100-00016)?

Hexoskin Medical System (7100-00016) is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Carre Technologies, Inc.. The 510(k) number is K243981.

When did Hexoskin Medical System (7100-00016) receive FDA 510(k) clearance?

Hexoskin Medical System (7100-00016) received FDA 510(k) clearance on 2025-11-18, under 510(k) number K243981.

Who is the listed applicant for Hexoskin Medical System (7100-00016)?

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

What is the FDA product code for Hexoskin Medical System (7100-00016)?

The FDA product code for Hexoskin Medical System (7100-00016) is DXH. This falls under the Hematology category.

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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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