Disposable Video Rhinolaryngoscope System (SP11A, M110B)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

Trade Name

Wesee

Generic Name

Endoscopic video image processing unit

Device Name

M110B

Model / Reference

M110B

Primary DI / UDI-DI

06976712916400

Basic UDI-DI

697671291M110BEN

Direct Marketing DI

06976712916400

510(k) Number

K253184 ↗

FDA Product Code

EOB

EMDN Code

Z12020406 Video processors

GMDN Term

Endoscopic video image processing unit

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 874.4760

EU market of registration

Spain

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

• Endoscopic Video Processor

  Class I

  CE/MDR

• Disposable Video Laryngoscope

  Class I

  CE/MDR

• Disposable Video Rhinolaryngoscope

  Class I

  CE/MDR GUDID on market

• Disposable Video Rhinolaryngoscope

  Class I

  CE/MDR GUDID on market

• What is the primary use case for the Video Rhinolaryngoscope System in clinical practice?

  The Video Rhinolaryngoscope System is designed for visual examination of the nasal passages, nasopharynx, and larynx, serving as a diagnostic and procedural guidance tool in otolaryngology. Its high-resolution imaging helps clinicians assess these areas during evaluations or interventions in hospital or outpatient settings where MRI safety is not a concern.

• Is the disposable rhinolaryngoscope component (SP11A) meant for single-use or reusable applications?

  The disposable rhinolaryngoscope (SP11A) is explicitly designed for single-use only, ensuring sterility and minimizing cross-contamination risks. This design choice aligns with clinical best practices for reducing infection transmission in sensitive procedures.

• How is the reusable endoscopic video processor (M110B) maintained, and what are the storage requirements?

  The reusable endoscopic video processor (M110B) requires proper storage and maintenance as specified by the manufacturer. Since it is not disposable, it must be cleaned, disinfected, and stored according to the manufacturer’s instructions to ensure functionality and longevity, particularly given its role in pairing with single-use disposable components.

• What regulatory pathways has this device undergone, and which medical specialty does it primarily serve?

  The Video Rhinolaryngoscope System has received FDA 510(k) clearance and complies with MDR (Medical Device Regulation) standards. It is classified under Device Class II (product code: EOB) and is intended for use in Ear, Nose, and Throat (ENT) specialties, as reflected in its regulatory filings and advisory committee classification.

• Are there any specific considerations for using this system in environments where MRI compatibility is a concern?

  The system is not designed for MRI-compatible use, as explicitly noted in its description. Clinicians should ensure the device is used in settings where MRI safety is not required, such as standard hospital or outpatient facilities, to avoid potential interference or safety risks.