PELVIC FLOOR REPAIR SYSTEM— 510(k) K091131

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K091131 for PELVIC FLOOR REPAIR SYSTEM, Substantially Equivalent on 2009-05-08. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2009-04-20
Decision date: 2009-05-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlboro, MA, US

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Adverse events under product code OTP

product code OTP

Injury: 1,061
Total: 1,061

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.