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510(k) K902349

SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER by Surgitek — Product Code FZW

K902349 is an FDA 510(k) premarket notification submitted by Surgitek for the device "SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800. Surgitek has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1990
Date Received
May 25, 1990
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 Surgitek

  • K946296 — QUADRA-COIL URETERAL STENT (March 6, 1995)
  • K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (February 7, 1995)
  • K943491 — RIGHT ANGLE UROLOGIC LASER FIBER (August 5, 1994)
  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 1993)
  • K930483 — URETERAL CATHETER (July 16, 1993)
  • K926344 — HYDROPHILIC COATED GUIDEWIRE (March 5, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)

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)
  • K883303 — MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (August 26, 1988)
  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)

FDA data resources