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)

Carevix™ Suction Cervical Stabilizer

K-Number: K223866 · 2023-01-25

ApplicantAspivix SA
Decision Date2023-01-25
Product CodeHDC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Carevix™ Suction Cervical Stabilizer is a medical device manufactured by Aspivix SA. It received FDA 510(k) clearance on 2023-01-25 under approval number K223866. The device is classified under product code HDC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carevix™ Suction Cervical Stabilizer?

Carevix™ Suction Cervical Stabilizer is a medical device that received FDA 510(k) clearance on 2023-01-25. It is manufactured by Aspivix SA. The 510(k) number is K223866.

When was Carevix™ Suction Cervical Stabilizer approved by the FDA?

Carevix™ Suction Cervical Stabilizer received FDA 510(k) clearance on 2023-01-25, under approval number K223866.

What company makes Carevix™ Suction Cervical Stabilizer?

Carevix™ Suction Cervical Stabilizer is manufactured by Aspivix SA.

What is the FDA product code for Carevix™ Suction Cervical Stabilizer?

The FDA product code for Carevix™ Suction Cervical Stabilizer is HDC.

Other Devices by Aspivix SA

Related Devices (Code: HDC)

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.