Class Class II
Carevix™ Suction Cervical Stabilizer (K223866)
Description
Carevix™ Suction Cervical Stabilizer by Aspivix SA, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223866
Clearance Date2023-01-25
Clearance TypeSpecial
Product CodeHDC
Regulation Number884.4530
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223866
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Carevix™ Suction Cervical Stabilizer (K223866) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021 |
Trace the full predicate network for K223866
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.