Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (K250432)
Description
Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) by Olympus Medical Systems Corporation, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250432
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. Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (K250432) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024 |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCO... | Olympus Medical Systems Corporation | 2023 |
| K131780 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corp. | 2013 |
Trace the full predicate network for K250432
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.