GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003— 510(k) K082054
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K082054 for GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003, Substantially Equivalent on 2008-08-06. Applicant: Gyrus Acmi, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyrus Acmi, 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
- Special
- Location
- Southborough, MA, 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.