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510(k) K895859

CONTAIN(TM) by Arbor Technologies, Inc. — Product Code GCX

K895859 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "CONTAIN(TM)". The FDA issued a decision of Substantially Equivalent on February 7, 1991. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Arbor Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1991
Date Received
October 3, 1989
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 Arbor Technologies, Inc.

  • K960928 — SYRINGEFILTER (April 4, 1997)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K922777 — PRESSURE TUBING AND ACCESSORIES (March 22, 1994)
  • K902666 — ANESTHESIA CONDUCTION FILTER (April 23, 1991)
  • K902167 — CONTAIN(TM) LASER PLUME FILTER (January 4, 1991)
  • K890844 — MICROSEPT 60/20 (June 7, 1989)
  • K874505 — CONTAIN(TM) (May 20, 1988)
  • K864113 — CLYDE (TM) FILTRATION SYSTEM (February 4, 1987)
  • K863162 — VACU-GUARD (August 29, 1986)

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