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510(k) K973273

XOMED T-STENT, FRONTAL SINUS STENT by Xomed, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
September 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Sinus
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code KAM

  • K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (October 7, 2011)
  • K093594 — MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (March 3, 2010)
  • K083574 — RELIEVA STRATUS MICROFLOW SPACER (January 29, 2009)
  • K072891 — SINUS SPACER (March 19, 2008)
  • K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (March 11, 2008)
  • K071845 — RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (September 28, 2007)
  • K062458 — ETHMOID SINUS SPACER (September 15, 2006)
  • K060974 — RELIENT NAVIGATION DEVICE (May 5, 2006)
  • K050340 — MICROMEDICS SPHENOID SINUS STENT (April 27, 2005)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)