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FDA 510(k)

Medical Shaver System (Morcellator) (YSB-IIIA)

K-Number: K251923 · 2026-01-29

ApplicantHangzhou Hawk Optical Electronic Instruments Co., Ltd.
Decision Date2026-01-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. The 510(k) number is K251923.

When was Medical Shaver System (Morcellator) (YSB-IIIA) approved by the FDA?

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

What company makes Medical Shaver System (Morcellator) (YSB-IIIA)?

Medical Shaver System (Morcellator) (YSB-IIIA) is manufactured by Hangzhou Hawk Optical Electronic Instruments Co., Ltd..

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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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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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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