K233614
- 510(k) number
- K233614
- Device name
- Genadyne DUO NPWT
- Applicant
- Genadyne Biotechnologies, Inc. NY · US
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2024-12-23
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K233614.pdf
Official FDA record: K233614
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.