510(k) clearances

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)

Kci USA, Inc. · General, Plastic Surgery

K241134Substantially EquivalentSpecialOMP
Open FDA's page for this record
Third party flag
N
City
San Antonio
Advisory committee description
General, Plastic Surgery
Address 1
6203 Farinon Dr.
Statement or summary
Summary
Product code
OMP
Zip code
78249
Applicant
Kci USA, Inc.
Decision date
2024-05-23
Decision code
SESE
Country code
US
Device name
3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
Advisory committee
SU
Contact
Jacqulyn Rosinski
K number
K241134
State
TX
Date received
2024-04-24
Review advisory committee
SU
Postal code
78249
Decision description
Substantially Equivalent
Clearance type
Special
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.