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510(k) K992149

GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 by Geiger Medical Technologies, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1999
Date Received
June 24, 1999
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 Geiger Medical Technologies, Inc.

  • K002341 — THERMAL CAUTERY UNIT, MODEL 150 (October 23, 2000)
  • K001029 — GEIGER NEEDLE ADAPTER, MODEL 406 (May 23, 2000)
  • K994075 — GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 (December 27, 1999)
  • K983852 — BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 (January 28, 1999)

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