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FDA 510(k)

Apex Flex

K-Number: K250617 · 2025-04-29

ApplicantSprintray, Inc.
Decision Date2025-04-29
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Apex Flex is a medical device manufactured by Sprintray, Inc.. It received FDA 510(k) clearance on 2025-04-29 under approval 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. It is manufactured by Sprintray, Inc.. The 510(k) number is K250617.

When was Apex Flex approved by the FDA?

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

What company makes Apex Flex?

Apex Flex is manufactured by Sprintray, Inc..

What is the FDA product code for Apex Flex?

The FDA product code for Apex Flex is EBI.

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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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