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FDA 510(k)

canturio® se (Canturio Smart Extension)

K-Number: K234056 · 2024-04-24

ApplicantCanary Medical USA, LLC
Decision Date2024-04-24
Product CodeQPP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

canturio® se (Canturio Smart Extension) is the device name listed in this FDA 510(k) record. The listed applicant is Canary Medical USA, LLC. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K234056. The device is classified under product code QPP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the canturio® se (Canturio Smart Extension)?

canturio® se (Canturio Smart Extension) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Canary Medical USA, LLC. The 510(k) number is K234056.

When did canturio® se (Canturio Smart Extension) receive FDA 510(k) clearance?

canturio® se (Canturio Smart Extension) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K234056.

Who is the listed applicant for canturio® se (Canturio Smart Extension)?

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

What is the FDA product code for canturio® se (Canturio Smart Extension)?

The FDA product code for canturio® se (Canturio Smart Extension) is QPP.

Other records listing Canary Medical USA, LLC 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.

K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemK220413Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

Related Devices (Code: QPP)

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.

K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLCK220413Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC

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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