EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM— 510(k) K112386

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K112386 for EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM, Substantially Equivalent on 2011-09-08. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2011-08-18
Decision date: 2011-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, 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.