FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EnSite X EP System
K Number: K260212
·
Decision Apr 20, 2026
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
57
Review Days
87
Basic Information
- Device Name
- EnSite X EP System
- K Number
- K260212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- January 23, 2026
- Decision Date
- April 20, 2026
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | Sep 4, 2025 | Substantially Equivalent |