FDA 510(k) clearance · back to tracker

Isolator Synergy EnCapture Ablation System (EMH)

AtriCure, Inc. cleared K234151 on 2024-08-27, decision: substantially equivalent

K-number

K234151

Sponsor

AtriCure, Inc.

Device

Isolator Synergy EnCapture Ablation System (EMH)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-08-27

Product code

OCL

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K234151on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.