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510(k) K920100

GSU HANDPIECE ADAPTER by Beacon Laboratories, Inc. — Product Code HAM

K920100 is an FDA 510(k) premarket notification submitted by Beacon Laboratories, Inc. for the device "GSU HANDPIECE ADAPTER". The FDA issued a decision of Substantially Equivalent on February 3, 1992. The device falls under product code HAM (Apparatus, Electrosurgical), 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
February 3, 1992
Date Received
January 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
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)
  • K925708 — DISPOSABLE ELECTROSURGERY BALL ELECTRODE (April 20, 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)
  • 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 HAM

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K894663 — BEAMER ONE (September 15, 1989)

FDA data resources