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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 the device name listed in this FDA 510(k) record. The listed applicant is Aspivix SA. It received FDA 510(k) clearance on 2023-01-25 under 510(k) 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. The listed applicant is Aspivix SA. The 510(k) number is K223866.

When did Carevix™ Suction Cervical Stabilizer receive FDA 510(k) clearance?

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

Who is the listed applicant for Carevix™ Suction Cervical Stabilizer?

The FDA 510(k) record lists Aspivix SA as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

NCT07290517Assessing Pain and Effectiveness of Carevix Device for IUD InsertionsRECRUITING

Other records listing Aspivix SA 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.

K203820ASPIVIX v1.1 Cervical Suction Tenaculum

Related Devices (Code: HDC)

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.

K203820ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA

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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