510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080292Substantially Equivalent

Epicor Ablation System

Abbott Medical, St. Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080292 is the FDA 510(k) clearance record for EPICOR ABLATION SYSTEM, a class II device, cleared for St Jude Medical on under FDA product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue). FDA's definition for product code OCL reads: "Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue". FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 2 recalls naming K080292.

Clearance record

Decision date
Received
(172 days to decision)
Product code
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
St Jude Medical 1350 Energy Ln., Suite 110, St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCL

Trailing 12 months

FDA records hold no clearances under product code OCL in the trailing twelve months.

FDA records show no clearances under product code OCL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260