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510(k) K895039

STERILE SALINE - FOR SUCTION CATHETER LUBRICATION by Aplicare, Inc. — Product Code GCX

K895039 is an FDA 510(k) premarket notification submitted by Aplicare, Inc. for the device "STERILE SALINE - FOR SUCTION CATHETER LUBRICATION". The FDA issued a decision of Substantially Equivalent on October 3, 1989. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Aplicare, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1989
Date Received
August 9, 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 Aplicare, Inc.

  • K923299 — APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK (January 18, 1994)
  • K873563 — APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY (November 23, 1987)
  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)
  • K861558 — APLICARE SKIN PROTECTANT SWABSTICK (June 4, 1986)
  • K833183 — APLICARE ONE ACETONE ALCOHOL SWABSTICK (October 31, 1983)
  • K833185 — ACETONE ALCOHOL PREP PAD (October 31, 1983)
  • K833184 — APLICARE THREE ALCOHOL SWABSTICKS (October 27, 1983)
  • K833182 — APLICARE ALCOHOL PREP PAD (October 27, 1983)

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