VacHeal Negative Pressure Wound Therapy System— 510(k) K254160
Substantially EquivalentVacHeal, LLC
FDA 510(k) clearance K254160 for VacHeal Negative Pressure Wound Therapy System, Substantially Equivalent on 2026-09-18. Applicant: VacHeal, LLC. Device class: 2.
Clearance details
- Applicant
- VacHeal, LLC
- Product code
- Code OKO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4683
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ardmore, PA, US
Recent devices under product code OKO
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