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510(k) K924577

MEDIVAC by Medisonic U.S.A., Inc. — Product Code GCX

K924577 is an FDA 510(k) premarket notification submitted by Medisonic U.S.A., Inc. for the device "MEDIVAC". The FDA issued a decision of Substantially Equivalent on March 23, 1993. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Medisonic U.S.A., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1993
Date Received
September 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Medisonic U.S.A., Inc.

  • K923660 — MEDISONIC OXYGEN FLOW CONTROLLER (January 27, 1993)
  • K901114 — MEDISONIC HUMDIFIER/INHALER (May 22, 1990)
  • K896192 — MEDISONIC PNEU-NEB (January 3, 1990)
  • K894961 — MEDISONIC ULTRA-SONIC INHALER (November 24, 1989)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources