EnSite X EP System— 510(k) K261729
Substantially EquivalentAbbott Medical
FDA 510(k) clearance K261729 for EnSite X EP System, Substantially Equivalent on 2026-09-17. Applicant: Abbott Medical. Device class: 2.
Summary
Abbott Medical submitted the EnSite X EP System under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the system beyond its name and code.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Abbott filed from St. Paul, Minnesota. The decision came 114 calendar days after FDA received it (May 26 to September 17, 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
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code DQK
view allMore clearances from Abbott Medical
view allAdverse 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.