EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS— 510(k) K083499
Substantially EquivalentColoplast A/S
FDA 510(k) clearance K083499 for EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS, Substantially Equivalent on 2009-05-08. Applicant: Coloplast A/S.
Clearance details
- Applicant
- Coloplast A/S
- Product code
- Code OTP
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code OTP
product code OTP- Injury
- 1,061
- Total
- 1,061
Source: openFDA MAUDE database, through . 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.