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510(k) K942495

SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM by Atos Medical AB — Product Code KAM

K942495 is an FDA 510(k) premarket notification submitted by Atos Medical AB for the device "SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Atos Medical AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
May 17, 1994
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 Atos Medical AB

  • K151404 — ProTrach Dualcare (February 12, 2016)
  • K141380 — PROVOX FREEHANDS FLEXIVOICE (September 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (October 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (October 14, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (June 5, 2009)
  • K072582 — PROVOX MICRON HME (May 30, 2008)
  • K043138 — PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (November 22, 2004)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (July 30, 2002)
  • K014102 — PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 (February 21, 2002)
  • K971244 — PROVOX 2 VOICE PROSTHESIS SYSTEM (June 6, 1997)

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)

FDA data resources