510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232295Substantially Equivalent

LAA Exclusion System

Syntheon, LLC, Miami FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232295 is the FDA 510(k) clearance record for LAA Exclusion System, a class II device, cleared for Syntheon, LLC on under FDA product code PZX (Left Atrial Appendage Clip, Implantable). FDA's definition for product code PZX reads: "Intended to occlude the left atrial appendage". FDA records list 3 510(k) clearances for Syntheon, LLC, from to . As of , FDA records show no recalls naming K232295.

Clearance record

Decision date
Received
(29 days to decision)
Product code
PZX Left Atrial Appendage Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Syntheon, LLC 13755 SW 119 Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZX

Trailing 12 months
2 clearances under product code PZX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260