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FDA 510(k)

EnSite™ X EP System

K-Number: K262006 · 2026-07-15

ApplicantAbbott Medical
Decision Date2026-07-15
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite™ X EP System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Medical. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K262006. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnSite™ X EP System?

EnSite™ X EP System is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is Abbott Medical. The 510(k) number is K262006.

When did EnSite™ X EP System receive FDA 510(k) clearance?

EnSite™ X EP System received FDA 510(k) clearance on 2026-07-15, under 510(k) number K262006.

Who is the listed applicant for EnSite™ X EP System?

The FDA 510(k) record lists Abbott Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnSite™ X EP System?

The FDA product code for EnSite™ X EP System is DQK.

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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