12 URETEROSCOPES/URETERO-RENOSCOPES— 510(k) K963855
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K963855 for 12 URETEROSCOPES/URETERO-RENOSCOPES, Substantially Equivalent on 1997-04-03. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code FGB
- 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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More clearances from Richard Wolf Medical Instruments Corp.
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- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
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.