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FDA 510(k)

ASPIVIX v1.1 Cervical Suction Tenaculum

K-Number: K203820 · 2021-08-17

ApplicantAspivix SA
Decision Date2021-08-17
Product CodeHDC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ASPIVIX v1.1 Cervical Suction Tenaculum is the device name listed in this FDA 510(k) record. The listed applicant is Aspivix SA. It received FDA 510(k) clearance on 2021-08-17 under 510(k) number K203820. 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 ASPIVIX v1.1 Cervical Suction Tenaculum?

ASPIVIX v1.1 Cervical Suction Tenaculum is a medical device that received FDA 510(k) clearance on 2021-08-17. The listed applicant is Aspivix SA. The 510(k) number is K203820.

When did ASPIVIX v1.1 Cervical Suction Tenaculum receive FDA 510(k) clearance?

ASPIVIX v1.1 Cervical Suction Tenaculum received FDA 510(k) clearance on 2021-08-17, under 510(k) number K203820.

Who is the listed applicant for ASPIVIX v1.1 Cervical Suction Tenaculum?

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 ASPIVIX v1.1 Cervical Suction Tenaculum?

The FDA product code for ASPIVIX v1.1 Cervical Suction Tenaculum 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.

K223866Carevix™ Suction Cervical Stabilizer

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.

K223866Carevix™ Suction Cervical StabilizerAspivix 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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