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FDA 510(k)

Dexus Prosthetic System (MSL2, MSR2)

K-Number: K262654 · 2026-08-27

ApplicantZhejiang Qiangnao Technology Co.,Ltd
Decision Date2026-08-27
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dexus Prosthetic System (MSL2, MSR2) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Qiangnao Technology Co.,Ltd. It received FDA 510(k) clearance on 2026-08-27 under 510(k) number K262654. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dexus Prosthetic System (MSL2, MSR2)?

Dexus Prosthetic System (MSL2, MSR2) is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is Zhejiang Qiangnao Technology Co.,Ltd. The 510(k) number is K262654.

When did Dexus Prosthetic System (MSL2, MSR2) receive FDA 510(k) clearance?

Dexus Prosthetic System (MSL2, MSR2) received FDA 510(k) clearance on 2026-08-27, under 510(k) number K262654.

Who is the listed applicant for Dexus Prosthetic System (MSL2, MSR2)?

The FDA 510(k) record lists Zhejiang Qiangnao Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dexus Prosthetic System (MSL2, MSR2)?

The FDA product code for Dexus Prosthetic System (MSL2, MSR2) is GXY.

Other records listing Zhejiang Qiangnao Technology Co.,Ltd as applicant

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.

K220002Dexus Prosthetics System (Model: MSL1, MSR1)

Related Devices (Code: GXY)

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.

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Official Source

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