510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052878Substantially Equivalent

Nt-1000

Neuro Therm, Inc., Middleton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K052878 is the FDA 510(k) clearance record for NT-1000, 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 no recalls naming K052878.

Clearance record

Decision date
Received
(103 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. 2 Debush Ave. Bldg. A2, Middleton MA
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