FDA.report

510(k) K251923

Device
Medical Shaver System (Morcellator) (YSB-IIIA)
Applicant
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
510(k) number
K251923
Product code
GCJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-29
Date received
2025-06-23
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Yayan Ding
Address
#9 Xinda Rd., Suoqian, Xiaoshan Hangzhou CN 311201 311201

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GCJ

510(k)DeviceApplicantDecision date
K254228KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG2026-05-11
K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd.2026-04-30
K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.2026-04-08
K260089TL-10 Laparoscopic Scope CleanerScopix , Ltd.2026-04-08
K252714C-Lant PortVigor Medical Technologies , Ltd.2026-02-27
K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc.2026-02-24
K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy2026-02-18
K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)Xenocor, Inc.2026-02-12
K252957Pneumo Dissector HookAb Medica Sas2026-01-23
K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlStryker Endoscopy2026-01-13
K250927KARL STORZ Cholangiography SetKarl Storz SE & CO. KG2025-11-22
K242606Nuvis® Wireless HD Camera System (Nuvis-2K)Integrated Endoscopy, Inc.2025-11-20
K252442Kii Structural Balloon Access SystemApplied Medical Resources Corp.2025-10-31
K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.2025-10-29
K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC2025-10-20