Home / 510(k) Clearances / K961880

510(k) K961880

MEDCARE SUCTION CONNECTING TUBING by Medcare Medical Group, Inc. — Product Code GCX

K961880 is an FDA 510(k) premarket notification submitted by Medcare Medical Group, Inc. for the device "MEDCARE SUCTION CONNECTING TUBING". The FDA issued a decision of Substantially Equivalent on July 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 Medical Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1996
Date Received
May 15, 1996
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 Medical Group, Inc.

  • K973497 — HUBERLOC (January 13, 1998)
  • K970152 — BIOPSY TRAY (March 5, 1997)
  • K962849 — CATHETER INSERTION TRAY (October 7, 1996)
  • K961075 — MEDCARE REGIONAL ANETHESIA KIT (September 6, 1996)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K962527 — GENERAL PURPOSE DENTAL TRAY (August 1, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)

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)
  • K960223 — CPR YANKAUER (March 28, 1996)
  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)

FDA data resources