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FDA 510(k)

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

K-Number: K252874 · 2025-10-08

ApplicantSerpex Medical, Inc.
Decision Date2025-10-08
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is a medical device manufactured by Serpex Medical, Inc.. It received FDA 510(k) clearance on 2025-10-08 under approval number K252874. 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 with Adapters SRA-1-01 and SRA-2-01?

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Serpex Medical, Inc.. The 510(k) number is K252874.

When was Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 approved by the FDA?

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 received FDA 510(k) clearance on 2025-10-08, under approval number K252874.

What company makes Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01?

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is manufactured by Serpex Medical, Inc..

What is the FDA product code for Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01?

The FDA product code for Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is KTI.

Other Devices by Serpex Medical, Inc.

K221206Compass Steerable Needle K221302Recon Steerable Sheath

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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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