Class Class II
UNIDRIVE SIII System (K223520)
Description
UNIDRIVE SIII System by Karl Storz-Endoscopy-America, Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223520
Clearance Date2023-04-27
Clearance TypeTraditional
Product CodeHIH
Regulation Number884.1690
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223520
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. UNIDRIVE SIII System (K223520) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K132015 | TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS | Smith & Nephew, Inc. | 2013 |
Trace the full predicate network for K223520
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.