OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device— 510(k) K221074
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K221074 for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device, Substantially Equivalent on 2022-09-16. Applicant: Stryker Corporation. Device class: 2.
Clearance details
- Applicant
- Stryker Corporation
- 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
- Portage, MI, US
Recent devices under product code GEI
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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.