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FDA 510(k)

Compass Steerable Needle

K-Number: K221206 · 2022-08-25

ApplicantSerpex Medical, Inc.
Decision Date2022-08-25
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Compass Steerable Needle is the device name listed in this FDA 510(k) record. The listed applicant is Serpex Medical, Inc.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) 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. The listed applicant is Serpex Medical, Inc.. The 510(k) number is K221206.

When did Compass Steerable Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Compass Steerable Needle?

The FDA 510(k) record lists Serpex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compass Steerable Needle?

The FDA product code for Compass Steerable Needle is KTI.

Other records listing Serpex Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01K221302Recon Steerable Sheath

Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

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.

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