FDA 510(k)

Recon Steerable Sheath

K-Number: K221302 · 2022-08-15

Decision Date2022-08-15

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Recon Steerable Sheath is a medical device manufactured by Serpex Medical, Inc.. It received FDA 510(k) clearance on 2022-08-15 under approval number K221302. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Recon Steerable Sheath?

Recon Steerable Sheath is a medical device that received FDA 510(k) clearance on 2022-08-15. It is manufactured by Serpex Medical, Inc.. The 510(k) number is K221302.

When was Recon Steerable Sheath approved by the FDA?

Recon Steerable Sheath received FDA 510(k) clearance on 2022-08-15, under approval number K221302.

What company makes Recon Steerable Sheath?

Recon Steerable Sheath is manufactured by Serpex Medical, Inc..

What is the FDA product code for Recon Steerable Sheath?

The FDA product code for Recon Steerable Sheath is EOQ.

Other Devices by Serpex Medical, Inc.

K221206Compass Steerable Needle K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.