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510(k) K924570

OEM MULTI-VAC POWERED SUCTION PUMP by Oem Medical Div. — Product Code GCX

K924570 is an FDA 510(k) premarket notification submitted by Oem Medical Div. for the device "OEM MULTI-VAC POWERED SUCTION PUMP". The FDA issued a decision of Substantially Equivalent on August 5, 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. Oem Medical Div. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 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 Oem Medical Div.

  • K925893 — OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT (March 12, 1993)
  • K922748 — GUEDEL AIRWAY (July 10, 1992)
  • K811855 — SKIN SCRUB KITS (July 31, 1981)
  • K761297 — MOUTHPIECE SEAL (January 3, 1977)

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