AMS ELEVATE PC— 510(k) K112842

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K112842 for AMS ELEVATE PC, Substantially Equivalent on 2011-10-25. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2011-09-29
Decision date: 2011-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, 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.