510(k) K231549— Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Substantially Equivalent

Boston Scientific Corporation

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2023-05-30
Decision date: 2023-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

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.