XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011— 510(k) K983628
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K983628 for XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011, Substantially Equivalent on 1998-12-11. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code GCT
- 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 GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
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.