510(k) K243317
- Device
- NUVENTUS NV.C Surgical Cassette and Tray
- Applicant
- Infinitum Eta, Ltd.
- 510(k) number
- K243317
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-11
- Date received
- 2024-10-22
- Regulation
- 880.6850
- Classification name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Avital Barlev
- Address
- Hatnufa St. 6 Petach Tikva IL 4951024 4951024
FDA Registration Numbers
- 1423662
- 3013283620
- 3015181082
- 3015895045
- 3026612481
- 3009540749
- 9613348
- 1416980
- 1450428
- 3043164947
- 3010393565
- 3006639944
- 3008517893
- 3011276344
- 3002808270
- 3006948427
- 3012507533
- 3010057495
- 2134470
- 3004464325
- 1421101
- 9680735
- 3010041430
- 3013357025
- 3013188547
- 3001617766
- 9680845
- 3023852420
- 1834331
- 3005741909
- 9612074
- 3009513193
- 3020767943
- 3013177549
- 3004112448
- 2023811
- 1833920
- 3017155536
- 1941138
- 3007695749
- 1058020
- 1319130
- 3034676720
- 3011050570
- 3005071827
- 1043653
- 3013557562
- 9610612
- 3010202439
- 3008791019
- 3011649314
- 1062741
- 2027754
- 9617542
- 3023155873
- 3004976965
- 3008959420
- 3004193466
- 3005004799
- 3010687973
- 1418479
- 2916714
- 1832228
- 3008719017
- 3009968482
- 3036622014
- 8010177
- 2424366
- 3014409963
- 3011533888
- 3027665899
- 3014553709
- 8010099
- 3016438694
- 8020776
- 3006554912
- 2248608
- 3003230618
- 3001082453
- 3006113180
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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