Hawkeye Control Unit with Eyas Endoscope— 510(k) K233115
Substantially EquivalentE Surgical, LLC
FDA 510(k) clearance K233115 for Hawkeye Control Unit with Eyas Endoscope, Substantially Equivalent on 2024-02-06. Applicant: E Surgical, LLC. Device class: 2.
Clearance details
- Applicant
- E Surgical, LLC
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, NV, US
Recent devices under product code HRX
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- K060255 — E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE
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.