ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280)
Description
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve by Ga Health Company Limited, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230280
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. ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K061313 | EVIS EXERA 180 SYSTEM | Olympus Medical Systems Corporation | 2006 |
Trace the full predicate network for K230280
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.