Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System— 510(k) K211223

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K211223 for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System, Substantially Equivalent on 2021-07-21. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2021-04-23
Decision date: 2021-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.