Zhuhai Wesee Meditech Co., Ltd. · Class II · Cleared Mar 25, 2026
| K-number | K253184 |
| Device name | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) |
| Applicant | Zhuhai Wesee Meditech Co., Ltd. |
| Product code | EOB |
| Device class | Class II |
| Decision date | Mar 25, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 874.4760 |
The Video Rhinolaryngoscope System consists of a sterile, single-use flexible endoscope (SP11A) and a reusable video processor (M110B). It is designed for endoscopic examination and procedures within the nasal lumens and upper airway in adults in hospital settings. The endoscope captures video via an embedded CMOS sensor and LED illumination, transmitting images to the processor for display on a monitor.
The subject endoscope has a 3.2mm distal end diameter and 3.6mm maximum insertion diameter with a 110° field of view, compared to the predicate's 3.5mm and 85° field of view respectively. The video processor features a 10.1-inch display screen and SD card storage, whereas the predicate has a 12.8-inch screen and USB drive storage. Both use LED illumination, 300mm working length, and identical bending angles (130° up/down).
ISO 8600-1, ISO 8600-3, ISO 8600-4 (endoscope performance); IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 (electrical safety and EMC); IEC 62471 (photobiological safety); ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); ISO 10993-7 (sterilization residuals); ASTM D4169, ASTM F88, ASTM F1929, ASTM F1886 (shelf life/packaging).
View the full FDA submission: accessdata.fda.gov