LITE PELVIC FLOOR REPAIR KITS— 510(k) K103426

Name: FDA 510(k) clearance K103426
Creator: U.S. Food and Drug Administration
Published: 2011-09-14

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K103426 for LITE PELVIC FLOOR REPAIR KITS, Substantially Equivalent on 2011-09-14. Applicant: Boston Scientific Corp. Device class: 3.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code OTP
Device class: Class 3
Regulation: 21 CFR 884.5980
Advisory panel: Obstetrics/Gynecology
Date received: 2010-11-22
Decision date: 2011-09-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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K112842 — AMS ELEVATE PC2011-10-25
K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08
K102815 — SURELIFT PROLAPSE SYSTEM2011-07-07

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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.