DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST— 510(k) K132199
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K132199 for DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST, Substantially Equivalent on 2013-10-03. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, 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
- Powell, TN, 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.