Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Canary Medical USA, LLC. It received FDA 510(k) clearance on 2024-04-24 under approval 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. It is manufactured by Canary Medical USA, LLC. The 510(k) number is K234056.

When was canturio® se (Canturio Smart Extension) approved by the FDA?

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

What company makes canturio® se (Canturio Smart Extension)?

canturio® se (Canturio Smart Extension) is manufactured by Canary Medical USA, LLC.

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

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

Related Clinical Trials

NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT04924205 A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy RECRUITING

Other Devices by Canary Medical USA, LLC

K220413Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

Related Devices (Code: QPP)

DEN200064Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical, Inc. K220413Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC

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.

↑