510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K262315Substantially Equivalent

NeuroBlate System

Monteris Medical, Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(57 days to decision)
Product code
ONO Neurosurgical Laser With Mr Thermography
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Monteris Medical 131 Cheshire Ln., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONO

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