MODIFICATION TO SURGICAL MESH POLYMERIC— 510(k) K040787

Name: FDA 510(k) clearance K040787
Creator: U.S. Food and Drug Administration
Published: 2004-04-14

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K040787 for MODIFICATION TO SURGICAL MESH POLYMERIC, Substantially Equivalent on 2004-04-14. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant: Boston Scientific
Product code: Product code OTN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2004-03-29
Decision date: 2004-04-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

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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.