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Carevix Suction Cervical Stabilizer

by Aspivix SA

510(k) K223866

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223866↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK223866 Date25 Jan 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HDC
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Carevix Suction Cervical Stabilizer is a Uterine Tenaculum designed to provide controlled stabilization of the cervix during obstetric and gynecological procedures. It combines suction and mechanical fixation to minimize cervical movement, reducing trauma and improving procedural precision in settings such as dilation and curettage or cervical biopsy.

This device is intended for single-use and is classified as Class II under FDA regulations, with FDA 510K clearance and MDR compliance. Supplied sterile in a sealed package, it is compatible with standard obstetric settings and adheres to MRI safety standards for non-ferromagnetic materials. Sizes and configurations are standardized for ease of use, and its design ensures minimal tissue displacement while maintaining stability during procedures.

Other devices from Aspivix SA

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures is the Carevix Suction Cervical Stabilizer primarily used for, and how does it improve outcomes?

    The Carevix Suction Cervical Stabilizer is designed for obstetric and gynecological procedures like dilation and curettage or cervical biopsy. It combines suction and mechanical fixation to minimize cervical movement, reducing trauma to the tissue and improving procedural precision. This dual-action approach helps maintain stability while allowing controlled access, which can lead to fewer complications and better outcomes.

  • Is the Carevix Suction Cervical Stabilizer reusable or intended for single-use, and how should it be stored?

    The Carevix Suction Cervical Stabilizer is explicitly intended for single-use only. It is supplied sterile in a sealed package, ensuring safety and sterility for one procedure. After use, it should be discarded, and unopened packages should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality.

  • What sizes or configurations are available for the Carevix Suction Cervical Stabilizer, and are they standardized?

    The Carevix Suction Cervical Stabilizer comes in standardized sizes and configurations to ensure ease of use across different clinical settings. While exact dimensions aren’t specified, the design is optimized for compatibility with standard obstetric procedures, reducing variability and improving consistency in handling.

  • Can the Carevix Suction Cervical Stabilizer be used in MRI environments, and why does this matter?

    Yes, the Carevix Suction Cervical Stabilizer is designed with non-ferromagnetic materials, making it compatible with MRI safety standards. This is important because it allows clinicians to use the device in MRI-equipped facilities without risking interference or patient safety concerns during imaging.

  • How was the regulatory pathway for the Carevix Suction Cervical Stabilizer determined, and what does this mean for clinicians?

    The device underwent an FDA 510(k) clearance process through the Obstetrics/Gynecology (OB) advisory committee, with a decision classified as Substantially Equivalent (SESE). This means the device was compared to a legally marketed predicate and found to have equivalent technological characteristics and safety. Clinically, this indicates it meets established standards for uterine tenacula in obstetrics/gynecology, ensuring reliability and compliance with regulatory requirements.