K252500
- 510(k) number
- K252500
- Device name
- CARA System
- Applicant
- Cara Medical, Ltd. VG
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-02-20
- Date received
- 2025-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252500.pdf
Official FDA record: K252500
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.