510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915741Substantially Equivalent

Disposable Monoplar Meddle Electrodes

Dantec Medical, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915741 is the FDA 510(k) clearance record for DISPOSABLE MONOPLAR MEDDLE ELECTRODES, a class I device, cleared for Dantec Medical, Inc. on under FDA product code GXE (Leukotome). FDA records list 25 510(k) clearances for Dantec Medical, Inc., from to . As of , FDA records show no recalls naming K915741.

Clearance record

Decision date
Received
(354 days to decision)
Product code
GXE Leukotome
Regulation
21 CFR 882.4600
Device class
Class I
Review panel
Neurology
Applicant
Dantec Medical, Inc. 1575 Eye St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code GXE

Trailing 12 months

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

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