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510(k) K970201

GSI CANNULA WITH INTRODUCER by General Surgical Innovations — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1997
Date Received
January 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by General Surgical Innovations

  • K983318 — FIXATION SYSTEM (March 1, 1999)
  • K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, (January 16, 1998)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION A (February 19, 1997)
  • K961356 — MAMMARY SIZER (September 23, 1996)
  • K952278 — THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA (August 7, 1995)
  • K951878 — SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA (June 29, 1995)
  • K944418 — THE SPACEMAKER AND THE SPACEMAKER II (November 1, 1994)
  • K944536 — GSI KNOTMAKER (October 5, 1994)
  • K943671 — GSI CANNULA REDUCER ACCESSORY (August 9, 1994)

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