Clearance Summary
Hawkeye Control Unit with Eyas Endoscope received FDA 510(k) clearance under submission number K233115, sponsored by E Surgical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-02-06.
- Submission: K233115
- Applicant / Sponsor: E Surgical, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2024-02-06
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.