RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES— 510(k) K042523
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K042523 for RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES, Substantially Equivalent on 2005-03-18. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code FJL
- 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 FJL
product code FJL- Death
- 2
- Total
- 2
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.