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510(k) K813082

UREOFIX 500 URINE MEASURING SYSTEM by Burron Medical Products, Inc. — Product Code FFG

K813082 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "UREOFIX 500 URINE MEASURING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 31, 1981. 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. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 2, 1981
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 Burron Medical Products, Inc.

  • K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)
  • K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
  • K860126 — STIMUPLEX, NERVE STIMULATOR (February 28, 1986)
  • K851293 — IMPLANTOFIX (January 9, 1986)
  • K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
  • K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
  • K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
  • K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
  • K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)

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)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K843224 — UROPUMP MODEL 1711 (October 19, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)

FDA data resources