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510(k) K983318

FIXATION SYSTEM by General Surgical Innovations — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1999
Date Received
September 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by General Surgical Innovations

  • K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, (January 16, 1998)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • K970201 — GSI CANNULA WITH INTRODUCER (April 21, 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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