Renasys Edge
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Hull
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 101 Hessle Rd.
- Statement or summary
- Summary
- Product code
- OMP
- Zip code
- HU3 2BN
- Applicant
- Smith & Nephew Medical, Ltd.
- Decision date
- 2024-05-24
- Decision code
- SESE
- Country code
- GB
- Device name
- Renasys Edge
- Advisory committee
- SU
- Contact
- Uttley Ruby
- K number
- K231939
- Date received
- 2023-06-30
- Review advisory committee
- SU
- Postal code
- HU3 2BN
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Negative Pressure Wound Therapy Powered Suction Pump
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4780
- Device class
- 2
- Registration number
- 3002807523, 3006808392, 3003775292, 1317547, 2244478, 3021090069, 3017397434, 3010149039, 1061124, 1055236, 3015219237, 3031289255, 3007048057, 3010155648, 3004111573, 3013857114, 3015143781, 3010610457, 3009518429, 3004727093, 3012084379, 3030172764, 1921846, 3008311916, 3008236846, 3030145672, 9613793, 1419937, 3007663067, 3021767551, 2435947, 3008806809, 3016904853, 3043172326, 3039256597, 3008132398, 3009655869, 3011987967, 3006581122, 3009176340 +65 more
- FEI number
- 3002807523, 3006808392, 3003775292, 3002807036, 1317547, 1000208624, 3006469671, 3021090069, 3017397434, 3010149039, 3015219237, 3031289255, 3002807091, 3007048057, 3010155648, 3004111573, 3013857114, 3015143781, 3010610457, 3001236905, 3009518429, 3004727093, 3012084379, 1000251124, 1000138054, 3030172764, 1921846, 3008311916, 3008236846, 1000121057, 3030145672, 1419937, 3007663067, 3003513125, 3021767551, 3008806809, 3016904853, 3043172326, 3003040625, 3039256597 +65 more