CURASYS 2 (EMDN0003)— 510(k) K253199
Substantially EquivalentCG Bio Co., Ltd.
FDA 510(k) clearance K253199 for CURASYS 2 (EMDN0003), Substantially Equivalent on 2026-06-23. Applicant: CG Bio Co., Ltd.. Device class: 2.
Summary
CG Bio's CURASYS 2 (EMDN0003) is filed under OMP, negative pressure wound therapy powered suction pumps. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 878.4780. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
CG Bio filed from Seoul, South Korea. Review took 270 calendar days (September 26, 2025 to June 23, 2026).
Clearance details
- Applicant
- CG Bio Co., Ltd.
- Product code
- Product code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code OMP
view all- K260306 — RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
- K261982 — RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
- K260426 — MeCare Alpha (MCA2019)
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
More clearances from CG Bio Co., Ltd.
view allAdverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.