FDA 510(k)

Apex Flex

K-Number: K250617 · 2025-04-29

Decision Date2025-04-29

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Apex Flex is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K250617. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apex Flex?

Apex Flex is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Sprintray, Inc.. The 510(k) number is K250617.

When did Apex Flex receive FDA 510(k) clearance?

Apex Flex received FDA 510(k) clearance on 2025-04-29, under 510(k) number K250617.

Who is the listed applicant for Apex Flex?

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

What is the FDA product code for Apex Flex?

The FDA product code for Apex Flex is EBI.

Other records listing Sprintray, Inc. 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.

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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.