Cleared Special

K223866 - Carevix™ Suction Cervical Stabilizer (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223866 · Aspivix SA · Obstetrics & Gynecology device
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Jan 2023
Decision
33d
Days
Class 2
Risk

K223866 is an FDA 510(k) clearance for the Carevix™ Suction Cervical Stabilizer. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Aspivix SA (Renens, CH). The FDA issued a Cleared decision on January 25, 2023 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aspivix SA devices

Submission Details

510(k) Number K223866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 160d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HDC Tenaculum, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.