iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (K221340)
Description
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) by Boston Scientific Corporation, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221340
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. iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (K221340) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212490 | AVVIGO Guidance System II | Boston Scientific Corporation | 2021 |
| K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS E... | Olympus Medical Systems Corp. | 2020 |
| K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needl... | Covidien, LLC | 2017 |
| K121564 | ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 | Olympus Medical Systems Corp. | 2012 |
Trace the full predicate network for K221340
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.