Mediclose Cartridge System— 510(k) K262044
Substantially EquivalentHealth Value Creation B.V. (trading as Corporis Medical)
FDA 510(k) clearance K262044 for Mediclose Cartridge System, Substantially Equivalent on 2026-10-14. Applicant: Health Value Creation B.V. (trading as Corporis Medical). Device class: 2.
Clearance details
- Applicant
- Health Value Creation B.V. (trading as Corporis Medical)
- Product code
- Product code OCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maastricht, NL
Recent devices under product code OCW
view allAdverse events under product code OCW
product code OCW- Death
- 6
- Injury
- 443
- Malfunction
- 1,023
- Other
- 2
- Total
- 1,474
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.