Class Class II
Ion Endoluminal System (IF 1000) (K242070)
Description
Ion Endoluminal System (IF 1000) by Intuitive Surgical, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242070
Clearance Date2024-09-24
Clearance TypeTraditional
Product CodeEOQ
Regulation Number874.4680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242070
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. Ion Endoluminal System (IF 1000) (K242070) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2023 |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 |
Trace the full predicate network for K242070
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.