510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080509Substantially Equivalent

Cardioblate 68000 Gnerator, Bp2 Surgical Ablation Device, Lp Surgical Ablation Device, Gemini-Ssurgical Ablation Device

Medtronic, Inc., Brooklyn Park MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080509 is the FDA 510(k) clearance record for CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE, a class II device, cleared for Medtronic, Inc. 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 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K080509.

Clearance record

Decision date
Received
(70 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
Medtronic, Inc. 7601 Northland Dr., Brooklyn Park 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260