Class Class II
External Drainage System (K221694)
Description
External Drainage System by Jmed(Shenzhen) Technology Limited, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221694
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeJXG
Regulation Number882.5550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221694
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. External Drainage System (K221694) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiT... | Integra LifeSciences Corporation | 2019 |
Trace the full predicate network for K221694
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.