FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avance Tubing, Avance Y-Connector, Avance ViewPad
K Number: K161797
·
Decision Oct 19, 2016
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
7
Review Days
111
Basic Information
- Device Name
- Avance Tubing, Avance Y-Connector, Avance ViewPad
- K Number
- K161797
- 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
- MOLNLYCKE HEALTH CARE, US LLC
- Date Received
- June 30, 2016
- Decision Date
- October 19, 2016
- 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.
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
Other Clearances by MOLNLYCKE HEALTH CARE, US LLC
| K Number | Device Name | ||
|---|---|---|---|
| K161935 | Avance Foam Dressing Kit - XL | Nov 4, 2016 | Substantially Equivalent |
| K161948 | Avance Gauze Dressing Kits | Nov 3, 2016 | Substantially Equivalent |
| K160379 | Exufiber Ag+ | Aug 25, 2016 | Substantially Equivalent |
| K152741 | Mepiseal Soft Silicone Sealant | Jan 22, 2016 | Substantially Equivalent |
| K151872 | Avance Y-Connector S | Nov 2, 2015 | Substantially Equivalent |
| K141719 | BIOGEL PL MICRO SURGICAL GLOVE | Sep 4, 2014 | Substantially Equivalent |