THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525— 510(k) K130423
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K130423 for THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525, Substantially Equivalent on 2013-04-03. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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.