510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K070311Substantially Equivalent

Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261

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

K070311 is the FDA 510(k) clearance record for CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261, a class II device, cleared for Medtronic Vascular on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K070311.

Clearance record

Decision date
Received
(82 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medtronic Vascular 7601 Northland Dr., Brooklyn Park MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GEI

Trailing 12 months
44 clearances under product code GEI in the twelve months to November 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20261
November 20260