PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM— 510(k) K122459

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K122459 for PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM, Substantially Equivalent on 2012-12-13. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2012-08-13
Decision date: 2012-12-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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.