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510(k) K923464

URODYNAMIC CATHETERS by R.L. Medical Corp. — Product Code FAP

K923464 is an FDA 510(k) premarket notification submitted by R.L. Medical Corp. for the device "URODYNAMIC CATHETERS". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
July 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances for product code FAP

  • K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE (December 13, 2012)
  • K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (February 19, 1998)
  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (August 27, 1996)
  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
  • K931179 — UROLAB SPECTRUM (November 18, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K924086 — NICKI, MODEL NUMBER USD-NK-UP1 (October 20, 1992)

FDA data resources