FDA 510(k)

Compass Steerable Needle

K-Number: K221206 · 2022-08-25

Decision Date2022-08-25

Product CodeKTI

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Compass Steerable Needle is a medical device manufactured by Serpex Medical, Inc.. It received FDA 510(k) clearance on 2022-08-25 under approval number K221206. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compass Steerable Needle?

Compass Steerable Needle is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Serpex Medical, Inc.. The 510(k) number is K221206.

When was Compass Steerable Needle approved by the FDA?

Compass Steerable Needle received FDA 510(k) clearance on 2022-08-25, under approval number K221206.

What company makes Compass Steerable Needle?

Compass Steerable Needle is manufactured by Serpex Medical, Inc..

What is the FDA product code for Compass Steerable Needle?

The FDA product code for Compass Steerable Needle is KTI.

Other Devices by Serpex Medical, Inc.

K221302Recon Steerable Sheath K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

Related Devices (Code: KTI)

K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC K152922ViziShot FLEXSpiration, Inc. K171232PeriView FLEXOlympus Surgical Technologies America K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation K163469ViziShot 2 FLEXOlympus Surgical Technologies America

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.