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510(k) K031026

ETI BIPOLAR HEMOSTATIC PROBE by Endo-Therapeutics, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2003
Date Received
March 31, 2003
Clearance Type
Traditional
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 Endo-Therapeutics, Inc.

  • K090796 — MULTI-BITE HOT BIOPSY FORCEPS (November 25, 2009)
  • K023603 — ENDO-GLIDE GUIDEWIRE (February 19, 2003)
  • K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGER (November 8, 2001)
  • K012977 — VARICES INJECTION NEEDLE (November 2, 2001)
  • K926549 — ENDOCATH ELECTROPHYSIOLOGY CATHETER (December 6, 1993)
  • K925392 — BIOPSY FORCEPS (November 5, 1993)

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