510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181864Substantially Equivalent

Polaris RF Ablation System

Baylis Medical Co., Inc., Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181864 is the FDA 510(k) clearance record for Polaris RF Ablation System, a class II device, cleared for Baylis Medical Company, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 53 510(k) clearances for Baylis Medical Company, Inc., from to . As of , FDA records show 6 recalls naming K181864.

Clearance record

Decision date
Received
(174 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Baylis Medical Company, Inc. 2775 Matheson Blvd. E., Mississauga, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXD

Trailing 12 months

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

FDA records show no clearances under product code GXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, 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