Home / 510(k) Clearances / K071845

510(k) K071845

RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A by Acclarent, Inc. — Product Code KAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2007
Date Received
July 5, 2007
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 Acclarent, Inc.

  • K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System (February 19, 2026)
  • K230742 — ACCLARENT AERA Eustachian Tube Dilation System (December 13, 2023)
  • K231862 — TruDi® Navigation System V3 (FG-2000-00) (July 21, 2023)
  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K190532 — TruDi NAV Wire (May 3, 2019)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K183090 — Relieva Tract Balloon Dilation System (April 19, 2019)

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)
  • 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)
  • K973273 — XOMED T-STENT, FRONTAL SINUS STENT (September 29, 1997)