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510(k) K942823

MAHE INSTRUMENTS by Mahe Intl., Inc. — Product Code DWG

K942823 is an FDA 510(k) premarket notification submitted by Mahe Intl., Inc. for the device "MAHE INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on December 5, 1994. The device falls under product code DWG (Electrosurgical Device), a Class II device regulated under 21 CFR 878.4400. Mahe Intl., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1994
Date Received
June 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical Device
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Mahe Intl., Inc.

  • K030857 — MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND END (October 16, 2003)
  • K991426 — MAHE INSTRUMENTS (August 5, 1999)

Other clearances for product code DWG

  • K932345 — TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE (April 12, 1994)
  • K931215 — HAND-TROL S (March 28, 1994)
  • K925708 — DISPOSABLE ELECTROSURGERY BALL ELECTRODE (April 20, 1993)

FDA data resources