Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591)
Description
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source by Schoelly Fiberoptic GmbH, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221591
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. Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; E... | Schoelly Fiberoptic GmbH | 2021 |
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount... | Stryker | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Cam... | Schoelly Fiberoptic GmbH | 2024 |
Trace the full predicate network for K221591
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.