510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180024Unknown

Leica FL400

Leica Microsystems (Schweiz) AG, Heerbrugg, CH / Direct, Unknown
FDA source (opens on fda.gov)

DEN180024 is the FDA 510(k) clearance record for Leica FL400, a class II device, cleared for Leica Microsystems (Schweiz) AG on under FDA product code QFX (Diagnostic Neurosurgical Microscope Filter). FDA's definition for product code QFX reads: "A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition". FDA records list 4 510(k) clearances for Leica Microsystems (Schweiz) AG, from to . As of , FDA records show no recalls naming DEN180024.

Clearance record

Decision date
Received
(335 days to decision)
Product code
QFX Diagnostic Neurosurgical Microscope Filter
Regulation
21 CFR 882.4950
Device class
Class II
Review panel
Neurology
Applicant
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201, Heerbrugg, CH
Third party review
No

Clearances, product code QFX

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