510(k) clearances

NUVENTUS NV.C™ Surgical Cassette and Tray

Infinitum Eta, Ltd. · General Hospital

K243317Substantially EquivalentTraditionalKCT
Open FDA's page for this record
Third party flag
N
City
Petach Tikva
Advisory committee description
General Hospital
Address 1
Hatnufa St. 6
Statement or summary
Summary
Product code
KCT
Zip code
4951024
Applicant
Infinitum Eta, Ltd.
Decision date
2025-02-11
Decision code
SESE
Country code
IL
Device name
NUVENTUS NV.C™ Surgical Cassette and Tray
Advisory committee
HO
Contact
Avital Barlev
K number
K243317
Date received
2024-10-22
Review advisory committee
HO
Postal code
4951024
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty description
General Hospital
Regulation number
880.6850
Device class
2
Registration number
8044099, 3010363542, 9610612, 3018094310, 3013114075, 3013247477, 3008868758, 3038187466, 8020776, 1062741, 8043792, 3014553709, 3015392401, 3016555232, 1057421, 3011824442, 3014409963, 3008837339, 3014421917, 3009538923, 3015612252, 9680261, 3012322232, 3007389669, 3005706667, 3011373951, 2184066, 3010707607, 9610773, 3026606306, 3036622014, 9612074, 3006742481, 1418479, 1314417, 3011063460, 3008864603, 3013111692, 3004203816, 3009050824 +258 more
FEI number
3010363542, 1000477302, 3018094310, 3013114075, 3013247477, 3008868758, 3038187466, 3014553709, 3003267134, 3015392401, 4224, 3016555232, 3011824442, 3014409963, 3008837339, 3014421917, 3009538923, 3015612252, 3012322232, 3007389669, 3005706667, 3011373951, 3002808269, 3010707607, 1000306694, 2523865, 3026606306, 3036622014, 1418479, 3006742481, 1000306303, 1314417, 3011063460, 3008864603, 3013111692, 3004203816, 3009050824, 1720499, 3008114965, 3003477135 +258 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.