Class Class II
Certas Plus Programmable Valves (K223330)
Description
Certas Plus Programmable Valves by Integra Lifesciences Production Corporation, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223330
Clearance Date2023-02-01
Clearance TypeTraditional
Product CodeJXG
Regulation Number882.5550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223330
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. Certas Plus Programmable Valves (K223330) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182265 | CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. | 2018 |
| K152152 | Codman Certas Plus Programmable Valve | Medos International SARL | 2015 |
| K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | Medos International SARL | 2015 |
Trace the full predicate network for K223330
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.