DeviceClearance

Hawkeye Control Unit with Eyas Endoscope— 510(k) K233115

Substantially Equivalent

E Surgical, LLC

FDA 510(k) clearance K233115 for Hawkeye Control Unit with Eyas Endoscope, Substantially Equivalent on 2024-02-06. Applicant: E Surgical, LLC.

Clearance details

Applicant
E Surgical, LLC
Product code
Code HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, NV, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.