Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System— 510(k) K231549
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K231549 for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System, Substantially Equivalent on 2023-06-29. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
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More clearances from Boston Scientific Corporation
view allAdverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
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.