FDA 510(k)

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

Номер K: K253184 · 2026-03-25

ЗаявительZhuhai Wesee Meditech Co., Ltd.

Дата решения2026-03-25

Код продуктаEOB

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: EOB)

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KG K261544Hydro Irrigation SystemStryker Instruments K254133ENTity USB Videoscope SystemOptim, LLC K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation K241731Outlook Surgical Versa One System (8900139)Resnent, LLC K243639Portare System (FA-001)Grumpy Innovation, Inc.

Официальный источник

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