510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941823Substantially Equivalent

Leksell Neuro Generator and Accessories

Elekta Instruments, Inc., Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941823 is the FDA 510(k) clearance record for LEKSELL NEURO GENERATOR AND ACCESSORIES, a class II device, cleared for Elekta Instruments, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 8 510(k) clearances for Elekta Instruments, Inc., from to . As of , FDA records show no recalls naming K941823.

Clearance record

Decision date
Received
(709 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Elekta Instruments, Inc. 8 Executive Park W., Atlanta GA
510(k) summary
Statement
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