Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
FDA 510(k) clearance K253184 · decided 2026-03-25
Clearance details
- K-number
- K253184
- Device name
- Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- Applicant
- Zhuhai Wesee Meditech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-03-25
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Zhuhai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.