Cleared Special

Carevix? Suction Cervical Stabilizer

K223866 · Aspivix SA · Obstetrics & Gynecology

Jan 2023

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K223866 is an FDA 510(k) clearance for the Carevix? Suction Cervical Stabilizer, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Aspivix SA (Renens, CH). The FDA issued a Cleared decision on January 25, 2023, 33 days after receiving the submission on December 23, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K223866 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2022
Decision Date	January 25, 2023
Days to Decision	33 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF