K233115
- 510(k) number
- K233115
- Device name
- Hawkeye Control Unit with Eyas Endoscope
- Applicant
- E Surgical, LLC NV · US
- Product code
- HRX — Arthroscope
- Decision date
- 2024-02-06
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233115.pdf
Official FDA record: K233115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.