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510(k) K843224

UROPUMP MODEL 1711 by Life-Tech Intl., Inc. — Product Code FFG

K843224 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "UROPUMP MODEL 1711". The FDA issued a decision of Substantially Equivalent on October 19, 1984. The device falls under product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable), a Class II device regulated under 21 CFR 876.1800. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
August 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Life-Tech Intl., Inc.

  • K001129 — PROLONG, MODELS PL50, PL100, PL150 (July 6, 2000)
  • K954505 — EZ STIM (December 10, 1996)
  • K955031 — MAXISTIM (December 10, 1996)
  • K954315 — PVC ABDOMINAL/RECTAL PRESSURE CATHETER (November 30, 1995)
  • K954341 — URODYNAMICS TUBING AND INFUSION SETS (October 17, 1995)
  • K953451 — UROPUMP TUBE & DAMPING CHAMGER (October 5, 1995)
  • K953353 — UROVISION JANUS (September 8, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K913601 — MICROPHOR (July 15, 1994)
  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 1994)

Other clearances for product code FFG

  • K893827 — PEAK FLOW RATE METER (August 11, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)
  • K813082 — UREOFIX 500 URINE MEASURING SYSTEM (December 31, 1981)

FDA data resources