FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
K Number: K243187
·
Decision Jun 27, 2025
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
3
Review Days
270
Basic Information
- Device Name
- Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
- K Number
- K243187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cork Medical
- Date Received
- September 30, 2024
- Decision Date
- June 27, 2025
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMP), ordered by most recent decision date.
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Genadyne DUO NPWT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSA Negative Pressure Wound Therapy System (VCMPP-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Negative Pressure Wound Therapy Device (V-Move, V-Grand)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXA NPWT System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Renasys Edge
FDA 510(k)
FDA Class 2
·General, Plastic Surgery