# K191102: Precision S 4K Sinuscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Sep 6, 2019 after 134 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K965233 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142249: Schoelly Sinuscope, Schoelly Fiberoptic GmbH (2015) Summary page 4.

## Most influential descendants
- K253602: Precision S 4K Sinuscope (2026), 0 descendants of its own
- K241731: Outlook Surgical Versa One System (8900139) (2025), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K191102
Methodology: https://510kreport.com/methodology