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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 a medical device manufactured by Aspivix SA. It received FDA 510(k) clearance on 2021-08-17 under approval 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. It is manufactured by Aspivix SA. The 510(k) number is K203820.

When was ASPIVIX v1.1 Cervical Suction Tenaculum approved by the FDA?

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

What company makes ASPIVIX v1.1 Cervical Suction Tenaculum?

ASPIVIX v1.1 Cervical Suction Tenaculum is manufactured by Aspivix SA.

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.

Other Devices by Aspivix SA

Related Devices (Code: HDC)

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.