K253199
- 510(k) number
- K253199
- Device name
- CURASYS 2 (EMDN0003)
- Applicant
- CG Bio Co., Ltd. KR
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2026-06-23
- Date received
- 2025-09-26
- 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: K253199.pdf
Official FDA record: K253199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.