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510(k) K020778

GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 by Gyrus Ent LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2002
Date Received
March 11, 2002
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 Gyrus Ent LLC

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  • K033089 — HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM (February 5, 2004)
  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING IN (May 2, 2003)
  • K021595 — GYRUS ENT NERVE STIMULATOR (October 24, 2002)
  • K021777 — GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND P (August 26, 2002)
  • K020067 — GYRUS ENT SOMNOPLASTY GENERATOR (April 4, 2002)
  • K020594 — DIEGO POWERED DISSECTOR AND DRILL SYSTEM (March 8, 2002)
  • K003214 — SMITH & NEPHEW PISTONS (October 31, 2000)

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