1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (K230216)
Description
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) by Stryker, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230216
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. 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (K230216) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | Stryker | 2022 |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source w... | Stryker | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | Stryker | 2023 |
Trace the full predicate network for K230216
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.