FDA 510(k)

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

Numéro K : K253184 · 2026-03-25

DemandeurZhuhai Wesee Meditech Co., Ltd.

Date de décision2026-03-25

Code produitEOB

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : EOB)

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Source officielle

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