Home / 510(k) Clearances / K923995

510(k) K923995

URODYNAMICS TUBING KITS #5161, #5150, #7170 by Advanced Medical Products, Inc. — Product Code FAP

K923995 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "URODYNAMICS TUBING KITS #5161, #5150, #7170". The FDA issued a decision of Substantially Equivalent on April 8, 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. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
August 10, 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 by Advanced Medical Products, Inc.

  • K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE, (October 20, 2011)
  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K921426 — ULTRA PCI (October 5, 1992)
  • K912925 — ULTRA PVD (June 18, 1992)
  • K915658 — SPECTRA ECG (June 10, 1992)
  • K896103 — MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (January 18, 1990)
  • K896102 — MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR (January 18, 1990)
  • K881905 — MODEL MICRO SI AMBULATORY ECG MONITOR (August 2, 1988)
  • K872508 — MODEL MICRO FD+ AMBULATORY ECG MONITOR (September 25, 1987)
  • K870537 — MODEL MICRO ST AMBULATORY ECG MONITOR (April 23, 1987)

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)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)
  • K924086 — NICKI, MODEL NUMBER USD-NK-UP1 (October 20, 1992)

FDA data resources