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510(k) K874276

CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER by Cox-Uphuff Intl. — Product Code FZW

K874276 is an FDA 510(k) premarket notification submitted by Cox-Uphuff Intl. for the device "CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on December 2, 1987. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800. Cox-Uphuff Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1987
Date Received
October 20, 1987
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 Cox-Uphuff Intl.

  • K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (November 13, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (May 22, 1987)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (January 12, 1987)
  • K854339 — CUI CHIN SIZER (November 15, 1985)
  • K853945 — CUI RHINOPLASTY IMPLANTS (October 18, 1985)
  • K831566 — CUI MAMMARY PROTHESIS SIZER (August 12, 1983)
  • K813394 — DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM (January 22, 1982)
  • K802214 — COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (October 23, 1980)

Other clearances for product code FZW

  • K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (May 2, 2008)
  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • 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)

FDA data resources