510(k) K242480
K242480 is an FDA 510(k) premarket notification submitted by 7D Surgical ULC for the device "FLASH EVD System (10-0002)". The FDA issued a decision of Substantially Equivalent on December 27, 2024. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2024
- Date Received
- August 21, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type