510(k) K243317
K243317 is an FDA 510(k) premarket notification submitted by Infinitum Eta, Ltd. for the device "NUVENTUS NV.C Surgical Cassette and Tray". The FDA issued a decision of Substantially Equivalent on February 11, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Infinitum Eta, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2025
- Date Received
- October 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type