SURELIFT PROLAPSE SYSTEM— 510(k) K102815
Substantially EquivalentNeomedic International
FDA 510(k) clearance K102815 for SURELIFT PROLAPSE SYSTEM, Substantially Equivalent on 2011-07-07. Applicant: Neomedic International. Device class: 3.
Clearance details
- Applicant
- Neomedic International
- Product code
- Code OTP
- Device class
- Class 3
- Regulation
- 21 CFR 884.5980
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code OTP
view allAdverse 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.