K243187
- 510(k) number
- K243187
- Device name
- Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
- Applicant
- Cork Medical IN · US
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2025-06-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243187.pdf
Official FDA record: K243187
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.