DeviceClearance

EnSite X EP System— 510(k) K262006

Substantially Equivalent

Abbott Medical

FDA 510(k) clearance K262006 for EnSite X EP System, Substantially Equivalent on 2026-07-15. Applicant: Abbott Medical. Device class: 2.

Summary

Abbott Medical's EnSite X EP System is filed under DQK, programmable diagnostic computers. The record doesn't expand "EP" or list the system's components.

Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Abbott filed from St. Paul, Minnesota. Review took 30 calendar days (June 15 to July 15, 2026).

Clearance details

Applicant
Abbott Medical
Product code
Product code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.