510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863135Substantially Equivalent

Low Profile Needle Electrode (N-Spyral Lp)

Neurotechnics, Inc., Annapolis MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863135 is the FDA 510(k) clearance record for LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP), a class II device, cleared for Neurotechnics, Inc. on under FDA product code GXZ (Electrode, Needle). FDA records list 2 510(k) clearances for Neurotechnics, Inc. As of , FDA records show no recalls naming K863135.

Clearance record

Decision date
Received
(385 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Neurotechnics, Inc. P.O. Box 6367, Annapolis MD
Third party review
No

Clearances, product code GXZ

Trailing 12 months

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

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