510(k) clearance
VacHeal Negative Pressure Wound Therapy System
- 510(k) number
- K254160
- Applicant
- VacHeal, LLC
- Decision date
- Sep 18, 2026
- Date received
- Dec 22, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OKO
- Device type
- Negative Pressure Wound Therapy Non-Powered Suction Apparatus
- Device class
- Class II
- Regulation
- 21 CFR 878.4683
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Ardmore, PA, US