Class Class II
MultiCut Solo (K213597)
Description
MultiCut Solo by Asclepion Laser Technologies GmbH, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213597
Clearance Date2023-01-18
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213597
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. MultiCut Solo (K213597) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K133272 | VERSACUT + TISSUE MORCELLATOR | Lumenis, Ltd. | 2014 |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PU... | Richard Wolf Medical Instruments Corp. | 2004 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2024 |
Trace the full predicate network for K213597
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.