FDA 510(k)

Medical Shaver System (Morcellator) (YSB-IIIA)

Número K: K251923 · 2026-01-29

RequerenteHangzhou Hawk Optical Electronic Instruments Co., Ltd.

Data da decisão2026-01-29

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Shaver System (Morcellator) (YSB-IIIA) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251923. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medical Shaver System (Morcellator) (YSB-IIIA)?

Medical Shaver System (Morcellator) (YSB-IIIA) is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. The 510(k) number is K251923.

When did Medical Shaver System (Morcellator) (YSB-IIIA) receive FDA 510(k) clearance?

Medical Shaver System (Morcellator) (YSB-IIIA) received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251923.

Who is the listed applicant for Medical Shaver System (Morcellator) (YSB-IIIA)?

The FDA 510(k) record lists Hangzhou Hawk Optical Electronic Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Shaver System (Morcellator) (YSB-IIIA)?

The FDA product code for Medical Shaver System (Morcellator) (YSB-IIIA) is GCJ.

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