Class Class II
System 9 Sterile Battery Container (K242834)
Description
System 9 Sterile Battery Container by Stryker Instruments, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242834
Clearance Date2025-01-16
Clearance TypeTraditional
Product CodeKCT
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242834
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. System 9 Sterile Battery Container (K242834) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 |
Trace the full predicate network for K242834
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.