FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (K244017)
Description
FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 by Fujifilm Corporation, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244017
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. FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (K244017) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | 2022 |
| K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 |
Trace the full predicate network for K244017
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.