BOSTON SCIENTIFIC SURGICAL MESH— 510(k) K081275

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K081275 for BOSTON SCIENTIFIC SURGICAL MESH, Substantially Equivalent on 2008-08-27. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2008-05-05
Decision date: 2008-08-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlboro, MA, US

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Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

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.