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510(k) K925708

DISPOSABLE ELECTROSURGERY BALL ELECTRODE by Beacon Laboratories, Inc. — Product Code DWG

K925708 is an FDA 510(k) premarket notification submitted by Beacon Laboratories, Inc. for the device "DISPOSABLE ELECTROSURGERY BALL ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code DWG (Electrosurgical Device), a Class II device regulated under 21 CFR 878.4400. Beacon Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
November 12, 1992
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 Beacon Laboratories, Inc.

  • K930243 — FLEXIBLE EXTENDER (March 11, 1994)
  • K930497 — ARGON HANDPIECES (June 25, 1993)
  • K922289 — SESQUIPOLAR(TM) MIS ELECTRODE (January 15, 1993)
  • K925619 — DISPOSABLE HAND-SWITCHING ESU PENCIL (December 24, 1992)
  • K915788 — MIS ELECTROSURGICAL ELECTRODES (March 13, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K913772 — PRESSURE GUARD (November 19, 1991)
  • K905752 — ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE (July 22, 1991)
  • K904506 — ACTIVE ADAPTER (December 13, 1990)
  • K902996 — ARGON BEAM LAPAROSCOPIC ELECTRODE (November 21, 1990)

Other clearances for product code DWG

  • K942823 — MAHE INSTRUMENTS (December 5, 1994)
  • K932345 — TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE (April 12, 1994)
  • K931215 — HAND-TROL S (March 28, 1994)

FDA data resources