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510(k) K904218

SUCTION SYSTEM by Axiom Medical, Inc. — Product Code GEA

K904218 is an FDA 510(k) premarket notification submitted by Axiom Medical, Inc. for the device "SUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1990. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Axiom Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1990
Date Received
September 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • K904133 — DISPOSABLE FLUID COLLECTION BAG (October 11, 1990)
  • K863247 — AXIOM TROCAR THORACIC CATHETER (August 29, 1986)
  • K861306 — SUCTION SYSTEM (June 9, 1986)
  • K852614 — ATRAUM WOUND DRESSING (August 30, 1985)

Other clearances for product code GEA

  • K003965 — MRI SAFE INSTRUMENTS (March 16, 2001)
  • K982472 — GENICON TROCAR (February 4, 1999)
  • K954599 — CONMED TROGARD ELECTRONIC TROCAR SYSTEM (November 27, 1995)
  • K922460 — ORIGIN SECONDARY CANNULA AND TROCAR (September 16, 1992)
  • K920110 — ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE (April 2, 1992)
  • K911262 — DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (June 20, 1991)
  • K904881 — DISPOSABLE YANKAUER SUCTION TUBE (March 6, 1991)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)
  • K901718 — KLEIN LAMPREY-CANNULA(TM) (May 24, 1990)

FDA data resources