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510(k) K984069

ENTAXIS NASAL PACKING by Les Laboratorires Brothier, S.A. — Product Code EMX

K984069 is an FDA 510(k) premarket notification submitted by Les Laboratorires Brothier, S.A. for the device "ENTAXIS NASAL PACKING". The FDA issued a decision of Substantially Equivalent on January 25, 1999. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Les Laboratorires Brothier, S.A. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1999
Date Received
November 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
Submission Type

Other clearances by Les Laboratorires Brothier, S.A.

  • K041446 — NASALCEASE (July 1, 2004)
  • K922540 — WOUND DRESSING (August 24, 1992)
  • K905314 — ALGODERM ALGINATE WOUND DRESSING (February 19, 1991)
  • K893123 — ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES (February 13, 1990)

Other clearances for product code EMX

  • K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (November 14, 2022)
  • K041446 — NASALCEASE (July 1, 2004)
  • K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR- (May 23, 2000)
  • K993362 — HYLASINE (March 13, 2000)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K982731 — MEROGEL NASAL DRESSING AND SINUS STENT (February 2, 1999)
  • K981966 — NOSEBLEED NOSECLIP (August 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)
  • K972922 — VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT (October 8, 1997)

FDA data resources