FDA 510(k) clearance · back to tracker

ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Genesee Biomedical, Inc. cleared K252917 on 2026-05-22, decision: substantially equivalent

K-number

K252917

Sponsor

Genesee Biomedical, Inc.

Device

ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-22

Product code

PZX

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4300

Official FDA record

Open K252917on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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