Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Related Devices (Code: GCJ)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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.

↑