FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
K Number: K153209
·
Decision Aug 4, 2016
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
211
Applicant Total
8
Review Days
273
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Basic Information
- Device Name
- RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
- K Number
- K153209
- 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, Ltd.
- Date Received
- November 5, 2015
- Decision Date
- August 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 |
Similar 510(k) Clearances
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Other Clearances by Smith & Nephew Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260646 | RENASYS EDGE (66803126) | May 27, 2026 | Substantially Equivalent |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Sep 11, 2025 | Substantially Equivalent |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Feb 18, 2025 | Substantially Equivalent |
| K231939 | Renasys Edge | May 24, 2024 | Substantially Equivalent |
| K190730 | IODOSORB | Dec 20, 2019 | Substantially Equivalent |
| K190756 | IODOFLEX | Dec 20, 2019 | Substantially Equivalent |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | Jan 28, 2016 | Substantially Equivalent |