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510(k) K954869

MEDCARE YANKAUER SUCTION DEVICE by Medcare Custom Packaging, Inc. — Product Code GCX

K954869 is an FDA 510(k) premarket notification submitted by Medcare Custom Packaging, Inc. for the device "MEDCARE YANKAUER SUCTION DEVICE". The FDA issued a decision of Substantially Equivalent on January 19, 1996. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Medcare Custom Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1996
Date Received
October 24, 1995
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 Medcare Custom Packaging, Inc.

  • K954442 — STERILE ISOTONIC SALINE & STERILE WATER (December 21, 1995)
  • K952759 — TOWEL PACK (September 29, 1995)
  • K950390 — URETHRAL CATHETERIZATION TRAY (May 30, 1995)
  • K943661 — STERILE PHYSIOLOGICAL SALINE/STERILE WATER (April 10, 1995)
  • K951149 — SINGLE USE INSTRUMENT TRAY (April 6, 1995)
  • K934732 — PELVIC EXAM TRAY (December 30, 1994)
  • K942000 — BURN DRESSING TRAY (May 20, 1994)
  • K936261 — CATHETER INSERTION TRAY (March 10, 1994)
  • K922179 — CATHETER INSERTION TRAY (July 2, 1993)
  • K901856 — CUSTOM WOUND MANAGEMENT KITS AND TRAYS (August 1, 1990)

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