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510(k) K915741

DISPOSABLE MONOPLAR MEDDLE ELECTRODES by Dantec Medical, Inc. — Product Code GXE

K915741 is an FDA 510(k) premarket notification submitted by Dantec Medical, Inc. for the device "DISPOSABLE MONOPLAR MEDDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on December 8, 1992. The device falls under product code GXE (Leukotome), a Class I device regulated under 21 CFR 882.4600. Dantec Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1992
Date Received
December 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Leukotome
Device Class
Class I
Regulation Number
882.4600
Review Panel
NE
Submission Type

Other clearances by Dantec Medical, Inc.

  • K960503 — DANTEC DUET (September 16, 1996)
  • K950314 — DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (March 25, 1996)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K926363 — MULTI-DOP S (June 19, 1995)
  • K931801 — MULTI-DOP X (June 14, 1995)
  • K930458 — MULTI-DOP L (February 3, 1995)
  • K932059 — NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (October 4, 1994)
  • K934580 — DANTEC 13R45 BAR ELECTRODE (September 26, 1994)
  • K931966 — DANTEC DISPOSABLE CONCENTRIC NEEDLE (March 30, 1994)
  • K931923 — DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) (November 9, 1993)

FDA data resources