ShenDa Sinuscope— 510(k) K161298

Substantially Equivalent

Shenyang Shenda Endoscope Co., Ltd.

FDA 510(k) clearance K161298 for ShenDa Sinuscope, Substantially Equivalent on 2017-08-25. Applicant: Shenyang Shenda Endoscope Co., Ltd..

Clearance details

Applicant: Shenyang Shenda Endoscope Co., Ltd.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2016-05-09
Decision date: 2017-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.