Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664)
Description
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) by Olympus Medical Systems Corporation, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251664
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. Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | 2019 |
| K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2017 |
Trace the full predicate network for K251664
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.