FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
K Number: K202157
·
Decision Oct 30, 2020
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
18
Review Days
88
Basic Information
- Device Name
- PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
- K Number
- K202157
- 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
- Smith & Nephew Medical Limited
- Date Received
- August 3, 2020
- Decision Date
- October 30, 2020
- 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 Smith & Nephew Medical Limited
| K Number | Device Name | ||
|---|---|---|---|
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Dec 17, 2024 | Substantially Equivalent |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | Aug 18, 2023 | Substantially Equivalent |
| K220964 | VERSAJET Hydrosurgery System (III) | May 16, 2023 | Substantially Equivalent |
| K223041 | Renasys Edge (66803126) | Nov 22, 2022 | Substantially Equivalent |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing | Jan 14, 2022 | Substantially Equivalent |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Dec 5, 2019 | Substantially Equivalent |
| K181822 | RENASYS Touch; RENASYS Y-Connector | Mar 21, 2019 | Substantially Equivalent |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy System | Jan 18, 2019 | Substantially Equivalent |
| K181204 | RENASYS Y-Connector; RENASYS TOUCH | Jan 10, 2019 | Substantially Equivalent |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Aug 21, 2018 | Substantially Equivalent |