VANGUARD REPROCESSED ARTHROSCOPIC WANDS— 510(k) K012695
Substantially EquivalentVanguard Medical Concepts, Inc.
FDA 510(k) clearance K012695 for VANGUARD REPROCESSED ARTHROSCOPIC WANDS, Substantially Equivalent on 2001-10-30. Applicant: Vanguard Medical Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Vanguard Medical Concepts, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakeland, FL, US
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Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.