510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K870028Substantially Equivalent

Smk Sluyter-Mehta Cannulae, RF Pole, Pole,flexible

Radionics, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870028 is the FDA 510(k) clearance record for SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE, a class II device, cleared for Radionics, Inc. on under FDA product code GXI (Probe, Radiofrequency Lesion). FDA records list 57 510(k) clearances for Radionics, Inc., from to . As of , FDA records show no recalls naming K870028.

Clearance record

Decision date
Received
(294 days to decision)
Product code
GXI Probe, Radiofrequency Lesion
Regulation
21 CFR 882.4725
Device class
Class II
Review panel
Neurology
Applicant
Radionics, Inc. P.O. Box 438, Burlington MA
Third party review
No

Clearances, product code GXI

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