EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209)
Description
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) by Cook Ireland, Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241209
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. EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023 |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore... | Cook Ireland, Ltd. | 2021 |
Trace the full predicate network for K241209
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.