K251923
- 510(k) number
- K251923
- Device name
- Medical Shaver System (Morcellator) (YSB-IIIA)
- Applicant
- Hangzhou Hawk Optical Electronic Instruments Co., Ltd. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-01-29
- Date received
- 2025-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251923.pdf
Official FDA record: K251923
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.