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FDA 510(k)

Su2ura Approximation Device

K-Number: K201744 · 2021-06-17

Decision Date2021-06-17
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Su2ura Approximation Device is a medical device manufactured by Anchora Medical, Ltd.. It received FDA 510(k) clearance on 2021-06-17 under approval number K201744. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Su2ura Approximation Device?

Su2ura Approximation Device is a medical device that received FDA 510(k) clearance on 2021-06-17. It is manufactured by Anchora Medical, Ltd.. The 510(k) number is K201744.

When was Su2ura Approximation Device approved by the FDA?

Su2ura Approximation Device received FDA 510(k) clearance on 2021-06-17, under approval number K201744.

What company makes Su2ura Approximation Device?

Su2ura Approximation Device is manufactured by Anchora Medical, Ltd..

What is the FDA product code for Su2ura Approximation Device?

The FDA product code for Su2ura Approximation Device is OCW.

Related Clinical Trials

Related Devices (Code: OCW)

Official Source

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