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510(k) K894602

B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) by Beacon Laboratories, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • 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)

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