HD-550 Video Endoscope System— 510(k) K211882

Substantially Equivalent

Sonoscape Medical Corp.

FDA 510(k) clearance K211882 for HD-550 Video Endoscope System, Substantially Equivalent on 2022-04-01. Applicant: Sonoscape Medical Corp..

Clearance details

Applicant: Sonoscape Medical Corp.
Product code: Code NWB
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-21
Decision date: 2022-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NWB

product code NWB

Malfunction: 12,503
Total: 12,503

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.