510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811726Substantially Equivalent

Leksell Stereoactic System

Downs Surgical, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811726 is the FDA 510(k) clearance record for LEKSELL STEREOACTIC SYSTEM, a class II device, cleared for Downs Surgical , Ltd. on under FDA product code LHF (Warmer, Microwave, Infusion Fluid). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K811726.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LHF Warmer, Microwave, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Downs Surgical , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHF

Trailing 12 months

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

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