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510(k) K972109

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER by General Surgical Innovations — Product Code FZW

K972109 is an FDA 510(k) premarket notification submitted by General Surgical Innovations for the device "SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER". The FDA issued a decision of Substantially Equivalent on November 14, 1997. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800. General Surgical Innovations has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1997
Date Received
June 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expander, Surgical, Skin Graft
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • 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)

Other clearances for product code FZW

  • K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (May 2, 2008)
  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K936186 — AESCULAP SKIN GRAFT MESHER (March 10, 1994)
  • K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (March 6, 1991)
  • K902349 — SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER (September 5, 1990)
  • K883303 — MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (August 26, 1988)
  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)

FDA data resources