Uro-Pro 2000
FDA 510(k) K922476 · Fiberoptic Sensor Technlogies, Inc.
510(k) numberK922476
Submission
- Device name
- Uro-Pro 2000
- Applicant
- Fiberoptic Sensor Technlogies, Inc.
Ann Arbor, MI, US - Received
- May 26, 1992
- Decision date
- July 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113771 | Signal Gear Urethral Catheter ElectrodeFAP · Traditional | Neurovision Medical Products, Inc. | 12/13/2012SE |
| K974775 | Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure GaugeFAP · Traditional | Airtronic Services, Inc. | 02/19/1998SE |
| K963330 | Urodynamic Analysis ModuleFAP · Traditional | Synectics Medical, Inc. | 04/03/1997SE |
| K962472 | Rusch Urodynamic Rectal Balloon 2-WAY CatheterFAP · Traditional | Rusch Intl. | 08/27/1996SE |
| K931175 | Schuster Disposable Balloon ProbeFAP · Traditional | Sandhill Scientific, Inc. | 04/01/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | Life-Tech Intl., Inc. | 11/18/1993SE |
| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | Synectics-Dantec | 06/18/1993SE |
| K923995 | Urodynamics Tubing Kits #5161, #5150, #7170FAP · Traditional | Advanced Medical Products, Inc. | 04/08/1993SE |
| K923464 | Urodynamic CathetersFAP · Traditional | R.L. Medical Corp. | 02/05/1993SE |
| K924086 | Nicki, Model Number USD-NK-UP1FAP · Traditional | Laborie Medical Technologies, Ltd. | 10/20/1992SE |
More from Laborie Medical Technologies, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K945753 | FST Fiberoptic Pressure ConverterFEN · Traditional | 05/11/1995SE |
| K950908 | FST Cath-Ud, CatheterFEN · Traditional | 04/07/1995SE |
| K945495 | 4-CHANNEL Urodynamic Monitor with Uro-Flo OptionEXY · Traditional | 02/09/1995SE |
| K930171 | FST Dual, Dual Pressure Urodynamics MonitorFEN · Traditional | 11/04/1993SE |
| K922776 | FST Council Tip Foley CatheterFEN · Traditional | 07/20/1993SE |
| K926088 | FST Cath Ud-Dual Dual Pressure CatheterFEN · Traditional | 06/18/1993SE |
| K913113 | FST Cath-Ud Catheter, ModificationFEN · Traditional | 10/09/1991SE |
| K913721 | FST Cath - Ui Usrodynamic Cath Introducer SystemFEN · Traditional | 10/08/1991SE |
| K905641 | FST Cath-Ud CatheterFEN · Traditional | 02/19/1991SE |
| K864000 | FST Disposable Fiber Optic Transducer #0100-00DXO · Traditional | 01/16/1987SE |
Questions and answers
When was Uro-Pro 2000 cleared by the FDA?
Uro-Pro 2000 (K922476) received a 510(k) decision of Substantially Equivalent on July 20, 1993, 420 days after the submission was received.
What is the product code of K922476?
The FDA product code is FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, a Class II (moderate risk) device regulated under 21 CFR 876.1620.