K254267
- 510(k) number
- K254267
- Device name
- NanoPress 760A-BT (760A-BT)
- Applicant
- Mego Afek , Ltd. IL
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2026-02-24
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K254267
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.