Home / 510(k) Clearances / K855039

510(k) K855039

MEDIFLEX INJECTION CAP by Mediflex Intl. — Product Code GCE

K855039 is an FDA 510(k) premarket notification submitted by Mediflex Intl. for the device "MEDIFLEX INJECTION CAP". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code GCE (Adaptor, Catheter), a Class I device regulated under 21 CFR 878.4200. Mediflex Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Mediflex Intl.

  • K915140 — PRIMARY DRESSING TRAY (February 11, 1992)
  • K900841 — HEMODIALYSIS TRANSDUCER PROTECTOR (May 15, 1990)
  • K891077 — MEDIVERSE PARENTERAL NUTRITION BAG (May 24, 1989)
  • K884243 — BLOOD TUBING SET (December 8, 1988)
  • K863496 — MEDIFLEX TRANSDUCER PROTECTOR (September 23, 1986)
  • K854346 — MEDIFLEX DISPOSABLE TUBING CLAMP (November 18, 1985)
  • K852106 — I.V. ADMINISTRATION SET (June 7, 1985)
  • K843126 — MEDIFLEX DRAINAGE BAG (October 4, 1984)

Other clearances for product code GCE

  • K901716 — KLEIN CONNECTOR(TM) (May 11, 1990)
  • K901715 — KLEIN CORK(TM) (May 11, 1990)
  • K801680 — BETA-CAP II ADAPTER (August 4, 1980)

FDA data resources