VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY— 510(k) K951245
Substantially EquivalentVidamed, Inc.
FDA 510(k) clearance K951245 for VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY, Substantially Equivalent on 1995-06-09. Applicant: Vidamed, Inc.. Device class: 2.
Clearance details
- Applicant
- Vidamed, 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
- Menlo Park, CA, 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.