Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K253184 · 2026-03-25

ApplicantZhuhai Wesee Meditech Co., Ltd.
Decision Date2026-03-25
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) is a medical device manufactured by Zhuhai Wesee Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-03-25 under approval number K253184. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)?

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Zhuhai Wesee Meditech Co., Ltd.. The 510(k) number is K253184.

When was Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) approved by the FDA?

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) received FDA 510(k) clearance on 2026-03-25, under approval number K253184.

What company makes Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)?

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) is manufactured by Zhuhai Wesee Meditech Co., Ltd..

What is the FDA product code for Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)?

The FDA product code for Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) is EOB.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED

Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Related Devices (Code: EOB)

K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH K153009ULTRA TelescopesOlympus Winter & Ibe GmbH K152531InstaClear Lens CleanerGyrus Acmi, Inc. K170453Medrobotics Flex Robotic SystemMedrobotics Corporation K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd. K170285AED SinuscopeNational Advanced Endoscopy Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑