FLASH EVD System (10-0002)
510(k)K242480NeurologyHAW
7D Surgical ULC is listed for FLASH EVD System (10-0002) (K242480). The FDA list gives December 27, 2024 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is HAW. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242480
- Date of final decision
- December 27, 2024
- Company on the FDA list
- 7D Surgical ULC
- Lead panel
- Neurology
- Primary product code
- HAW
- openFDA device name for the code
- Neurological Stereotaxic Instrument
- Device class
- 2
- Regulation number
- 882.4560
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary