510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K896450Substantially Equivalent

Neuro N 50 Lesion Generator

Leibinger & Fischer, Ltd., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896450 is the FDA 510(k) clearance record for NEURO N 50 LESION GENERATOR, a class II device, cleared for Leibinger & Fischer , Ltd. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 2 510(k) clearances for Leibinger & Fischer , Ltd., from to . As of , FDA records show no recalls naming K896450.

Clearance record

Decision date
Received
(495 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Leibinger & Fischer , Ltd. 4500 Trammell Crow Center, Dallas TX
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