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510(k) K924944

INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA by Westmed Intl. — Product Code EMX

K924944 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA". The FDA issued a decision of Substantially Equivalent on July 2, 1993. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Westmed Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1993
Date Received
September 30, 1992
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 Westmed Intl.

  • K955047 — WESTMED CIRCULARIE PEP DEVICES (March 27, 1996)
  • K954271 — WESTMED CONDESATE COLLECTION TRAP (December 28, 1995)
  • K952616 — MICROTIME (September 27, 1995)
  • K953687 — WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (September 18, 1995)
  • K953506 — WESTMED RESPIRATORY LUER ADAPTOR (September 15, 1995)
  • K951484 — WESTMED BACTERIAL/VIRAL FILTER (April 24, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K925173 — BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (January 15, 1993)

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)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K981966 — NOSEBLEED NOSECLIP (August 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)

FDA data resources