FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Invia Abdominal Dressing Kit
K Number: K182191
·
Decision Feb 1, 2019
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
211
Applicant Total
30
Review Days
172
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Basic Information
- Device Name
- Invia Abdominal Dressing Kit
- K Number
- K182191
- 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
- Medela AG
- Date Received
- August 13, 2018
- Decision Date
- February 1, 2019
- 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 Medela AG
| K Number | Device Name | ||
|---|---|---|---|
| K251377 | Magic InBra | Sep 18, 2025 | Substantially Equivalent |
| K223388 | Invia® Integrated Dressing | Jul 7, 2023 | Substantially Equivalent |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | Jul 26, 2022 | Substantially Equivalent |
| K191653 | Freestyle Flex | Oct 17, 2019 | Substantially Equivalent |
| K180415 | Invia White Foam NPWT | Nov 2, 2018 | Substantially Equivalent |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | May 9, 2018 | Substantially Equivalent |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | Apr 6, 2017 | Substantially Equivalent |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply | Dec 1, 2016 | Substantially Equivalent |
| K153663 | Vario 8/18/ci | May 18, 2016 | Substantially Equivalent |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | Nov 5, 2015 | Substantially Equivalent |