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FDA 510(k)

Bi-Flex Evo

K-Number: K182144 · 2018-09-07

ApplicantPromepla Sam
Decision Date2018-09-07
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bi-Flex Evo is a medical device manufactured by Promepla Sam. It received FDA 510(k) clearance on 2018-09-07 under approval number K182144. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bi-Flex Evo?

Bi-Flex Evo is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Promepla Sam. The 510(k) number is K182144.

When was Bi-Flex Evo approved by the FDA?

Bi-Flex Evo received FDA 510(k) clearance on 2018-09-07, under approval number K182144.

What company makes Bi-Flex Evo?

Bi-Flex Evo is manufactured by Promepla Sam.

What is the FDA product code for Bi-Flex Evo?

The FDA product code for Bi-Flex Evo is KNY.

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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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