510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052357Substantially Equivalent

Pathway - Ats/cheps

Medoc Ltd. Advanced Medical Systems, Somerset MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052357 is the FDA 510(k) clearance record for PATHWAY - ATS/CHEPS, a class II device, cleared for Medoc Ltd. Advanced Medical Systems on under FDA product code NTU (Evoked Potential Stimulator, Thermal). FDA's definition for product code NTU reads: "Intended to evaluate the functionality of human pain reception and transmission of sensory pathways". FDA records list 4 510(k) clearances for Medoc Ltd. Advanced Medical Systems, from to . As of , FDA records show no recalls naming K052357.

Clearance record

Decision date
Received
(143 days to decision)
Product code
NTU Evoked Potential Stimulator, Thermal
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Medoc Ltd. Advanced Medical Systems 291 Hillside Ave., Somerset MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTU

Trailing 12 months

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

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