# K253602: Precision S 4K Sinuscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jun 4, 2026 after 198 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K930667 (1994). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes, Stryker (2021) Summary page 5.
- K191102: Precision S 4K Sinuscope, Stryker (2019) Summary page 5.

## Indications for use
The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age.

Source page: https://510kreport.com/device/K253602
Methodology: https://510kreport.com/methodology