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Data / Medical devices / China / Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

Hangzhou Hawk Optical Electronic Instruments Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance

Hangzhou Hawk Optical Electronic Instruments Co., Ltd. is registered with the FDA (registration 3014296178) in Hangzhou Zhejiang, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3014296178
Address
No.9, Xinda Road, Suoqian, Xiaoshan, Hangzhou Zhejiang, China, 311201
Owner or operator
Hangzhou Hawk Optical Electronic Instruments Co., Ltd. (10095431)
Roles
Manufacturer
First device listed
March 12, 2026
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 29, 2026K251923Medical Shaver System (Morcellator) (YSB-IIIA)GCJSubstantially EquivalentHangzhou Hawk Optical Electronic Instruments Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.