510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111576Substantially Equivalent

Nt 2000 Lesioning Generator

Neuro Therm, Inc., Ashland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111576 is the FDA 510(k) clearance record for NT 2000 LESIONING GENERATOR, a class II device, cleared for Neuro Therm, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 3 510(k) clearances for Neuro Therm, Inc., from to . As of , FDA records show 4 recalls naming K111576.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Neuro Therm, Inc. 200 Homer Ave., Ashland MA
510(k) summary
Summary PDF
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