K253184
- 510(k) number
- K253184
- Device name
- Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- Applicant
- Zhuhai Wesee Meditech Co., Ltd. CN
- Product code
- EOB — Nasopharyngoscope (Flexible Or Rigid)
- Decision date
- 2026-03-25
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K253184.pdf
Official FDA record: K253184
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.