FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avance Foam Dressing Kit - XL
K Number: K161935
·
Decision Nov 4, 2016
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
7
Review Days
113
Basic Information
- Device Name
- Avance Foam Dressing Kit - XL
- K Number
- K161935
- 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
- July 14, 2016
- Decision Date
- November 4, 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 |
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Other Clearances by MOLNLYCKE HEALTH CARE, US LLC
| K Number | Device Name | ||
|---|---|---|---|
| K161948 | Avance Gauze Dressing Kits | Nov 3, 2016 | Substantially Equivalent |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | Oct 19, 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 |