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510(k) K113771

SIGNAL GEAR URETHRAL CATHETER ELECTRODE by Neurovision Medical Products, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
December 22, 2011
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 Neurovision Medical Products, Inc.

  • K130570 — NEUROVISION MEDICAL MOTION SENSOR (December 26, 2013)
  • K130806 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (July 12, 2013)
  • K121931 — NONDISPOSABLE STIMULATING INSTRUMENTS (October 19, 2012)
  • K110989 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (November 3, 2011)
  • K110140 — NEUROVISION NERVE LOCATOR MONITOR (September 30, 2011)
  • K110712 — DRYTOUCH SUCTION STIMULATOR PROBE (June 28, 2011)
  • K110138 — PAIRED HYDROGEL ELECTRODE (April 8, 2011)
  • K102862 — NEUROVISION SE (NERVEANA) (December 21, 2010)

Other clearances for product code FAP

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