# K161298: ShenDa Sinuscope

- Pathway: 510(k) (Traditional)
- Applicant: Shenyang Shenda Endoscope Co., Ltd.
- Decided: Aug 25, 2017 after 473 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: 1 generation back to K965233 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965233: Sharpsite AC, Xomed, Inc. (1997) Summary page 6.

## Indications for use
ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

Source page: https://510kreport.com/device/K161298
Methodology: https://510kreport.com/methodology