Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)— 510(k) K253184
Substantially EquivalentZhuhai 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.. Device class: 2.
Summary
Zhuhai Wesee Meditech's Video Rhinolaryngoscope System is filed under EOB, flexible or rigid nasopharyngoscopes. The name lists two parts, the Disposable Video Rhinolaryngoscope SP11A and the Endoscopic Video Processor M110B.
Class II, 21 CFR 874.4760. It was a Traditional 510(k), and Ear, Nose, and Throat is both the classification panel and the review panel.
Zhuhai Wesee Meditech filed from Zhuhai, China. The decision came 180 calendar days after FDA received it (September 26, 2025 to March 25, 2026).
Clearance details
- Applicant
- Zhuhai Wesee Meditech Co., Ltd.
- Product code
- Product code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhuhai, CN
Recent devices under product code EOB
view allAdverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . 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.