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510(k) K895842

BITOME(TM) BIPOLAR SPHINCTEROTOME by Everest Medical Corp. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
October 2, 1989
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 Everest Medical Corp.

  • K003060 — PLASMAKINETIC GENERATOR (October 31, 2000)
  • K000496 — EVERSHEARS BIPOLAR SCISSORS (April 24, 2000)
  • K993412 — BITX PROBES (March 31, 2000)
  • K994336 — BITX PROBES (February 8, 2000)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K955001 — EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS (December 13, 1995)
  • K945975 — EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS (December 21, 1994)
  • K922509 — LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA (October 1, 1992)
  • K922246 — TUBING SET W/ IRRIGATION & ASPIRATION VALVING (September 2, 1992)
  • K920089 — MONOPOLAR COAGULATING POLYPECTOMY SNARE (March 31, 1992)

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