510(k) clearances

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

Smith & Nephew Medical, Ltd. · General, Plastic Surgery

K243576Substantially EquivalentTraditionalOMP
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
2025-02-18
Decision code
SESE
Country code
GB
Device name
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
Advisory committee
SU
Contact
Ruby Uttley
K number
K243576
Date received
2024-11-19
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.