FloNavi Endoscopic Fluorescence Imaging System (K221861)
Description
FloNavi Endoscopic Fluorescence Imaging System by Guangdong Optomedic Technologies, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221861
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. FloNavi Endoscopic Fluorescence Imaging System (K221861) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Pa... | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241530 | Stellar Imaging System | Guangdong Optomedic Technologies, Inc. | 2024 |
Trace the full predicate network for K221861
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.