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510(k) K950109

CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER by Cypress Medical Products, Ltd. — Product Code FCM

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 27, 1995
Date Received
January 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Cypress Medical Products, Ltd.

  • K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (July 12, 2002)
  • K012282 — STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (August 6, 2001)
  • K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (July 7, 1998)
  • K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (May 28, 1998)
  • K972883 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (February 26, 1998)
  • K952367 — CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (July 5, 1995)
  • K950254 — CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (March 31, 1995)
  • K950092 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY (February 27, 1995)
  • K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPE (December 8, 1994)
  • K921988 — LACERATION REPAIR TRAY (November 19, 1992)

Other clearances for product code FCM

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  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)