Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)— 510(k) K253184

Substantially Equivalent

Zhuhai Wesee Meditech Co., Ltd.

FDA 510(k) clearance K253184 for Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B), Substantially Equivalent on 2026-03-25. Applicant: Zhuhai Wesee Meditech Co., Ltd..

Clearance details

Applicant: Zhuhai Wesee Meditech Co., Ltd.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2025-09-26
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, 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.