Magma Spark— 510(k) K162781
Substantially EquivalentFormatk Systems , Ltd.
FDA 510(k) clearance K162781 for Magma Spark, Substantially Equivalent on 2016-11-09. Applicant: Formatk Systems , Ltd.. Device class: 2.
Clearance details
- Applicant
- Formatk Systems , Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tirat Carmel, IL
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More clearances from Formatk Systems , Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.