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510(k) K922476

URO-PRO 2000 by Fiberoptic Sensor Technlogies, Inc. — Product Code FAP

K922476 is an FDA 510(k) premarket notification submitted by Fiberoptic Sensor Technlogies, Inc. for the device "URO-PRO 2000". The FDA issued a decision of Substantially Equivalent on July 20, 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. Fiberoptic Sensor Technlogies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1993
Date Received
May 26, 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 Fiberoptic Sensor Technlogies, Inc.

  • K945753 — FST FIBEROPTIC PRESSURE CONVERTER (May 11, 1995)
  • K950908 — FST CATH-UD, CATHETER (April 7, 1995)
  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR (November 4, 1993)
  • K922776 — FST COUNCIL TIP FOLEY CATHETER (July 20, 1993)
  • K926088 — FST CATH UD-DUAL DUAL PRESSURE CATHETER (June 18, 1993)
  • K913113 — FST CATH-UD CATHETER, MODIFICATION (October 9, 1991)
  • K913721 — FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (October 8, 1991)
  • K905641 — FST CATH-UD CATHETER (February 19, 1991)
  • K864000 — FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 (January 16, 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)
  • 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)

FDA data resources