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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 the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Wesee Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-03-25 under 510(k) 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. The listed applicant is Zhuhai Wesee Meditech Co., Ltd.. The 510(k) number is K253184.

When did Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) receive FDA 510(k) clearance?

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

Who is the listed applicant for Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)?

The FDA 510(k) record lists Zhuhai Wesee Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.K243380VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems Corporation

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.

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