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510(k) K915166

MICROCYCLER by Medical Inventors Corp., Inc. — Product Code FCN

K915166 is an FDA 510(k) premarket notification submitted by Medical Inventors Corp., Inc. for the device "MICROCYCLER". The FDA issued a decision of Substantially Equivalent on September 7, 1994. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medical Inventors Corp., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1994
Date Received
November 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Drainage Collection Kit, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Medical Inventors Corp., Inc.

  • K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (July 14, 1989)

Other clearances for product code FCN

  • K951443 — STANDARD FOLEY SYSTEM PAK (June 15, 1995)
  • K945258 — CATCO URINARY COLLECTION KIT (February 16, 1995)
  • K922346 — FEMALE URINE SAMPLING DEVICE (August 14, 1992)
  • K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (July 14, 1989)
  • K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEM (December 19, 1988)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K780134 — URINARY DRAINAGE MONITORING SYSTEM (February 2, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771210 — UROGARD URINARY DRAINAGE BAG (July 11, 1977)

FDA data resources