Home / 510(k) Clearances / K832476

510(k) K832476

SILICONE SOFT-PAK EPISTAXIS CATHETER by Axiom Medical, Inc. — Product Code ENW

K832476 is an FDA 510(k) premarket notification submitted by Axiom Medical, Inc. for the device "SILICONE SOFT-PAK EPISTAXIS CATHETER". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code ENW (Catheter, Nasopharyngeal), a Class I device regulated under 21 CFR 874.4175. Axiom Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
July 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nasopharyngeal
Device Class
Class I
Regulation Number
874.4175
Review Panel
EN
Submission Type

Other clearances by Axiom Medical, Inc.

  • K993592 — AXIOM MULTIPURPOSE WOUND DRAIN (May 17, 2000)
  • K971851 — INTERPLEURAL ANESTHESIA CATHETER (January 22, 1998)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)
  • K934895 — GLASSMAN SILICONE CATHETER (October 13, 1994)
  • K922760 — ATRAUM WOUND DRESSING--MODIFICATION (October 30, 1992)
  • K905422 — PVC ROUND WOUND DRAINS (February 11, 1991)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K904133 — DISPOSABLE FLUID COLLECTION BAG (October 11, 1990)
  • K863247 — AXIOM TROCAR THORACIC CATHETER (August 29, 1986)
  • K861306 — SUCTION SYSTEM (June 9, 1986)

Other clearances for product code ENW

  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)

FDA data resources