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510(k) K003569

PLASMAKINETIC ENDOUROLOGY SYSTEM by Gyrus Medical , Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2000
Date Received
November 20, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Gyrus Medical , Ltd.

  • K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR (November 9, 2005)
  • K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES (October 25, 2005)
  • K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM (March 2, 2005)
  • K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA (October 22, 2004)
  • K041285 — GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION (September 10, 2004)
  • K024286 — GYRUS OPEN FORCEPS (November 17, 2003)
  • K031085 — GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) (July 21, 2003)
  • K031082 — EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK (May 21, 2003)
  • K031079 — EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE (May 21, 2003)
  • K031081 — EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS (May 21, 2003)

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