FST Cath Ud-Dual Dual Pressure Catheter
FDA 510(k) K926088 · Fiberoptic Sensor Technlogies, Inc.
510(k) numberK926088
Submission
- Device name
- FST Cath Ud-Dual Dual Pressure Catheter
- Applicant
- Fiberoptic Sensor Technlogies, Inc.
Ann Arbor, MI, US - Received
- December 2, 1992
- Decision date
- June 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FEN – Device, Cystometric, Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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| K001386 | Accuset Sensor, Model 2000FEN · Traditional | Pelvicare, Inc. | 07/17/2000SE |
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| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | Influence, Inc. | 11/24/1998SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | Circon Video | 10/24/1997SE |
| K971911 | Lumax Cystometry Administration Tube SetFEN · Traditional | Medamicus, Inc. | 06/03/1997SE |
| K964522 | Ellipse 4FEN · Traditional | Andromeda Medizinische Systeme GmbH | 03/21/1997SE |
| K960503 | Dantec DuetFEN · Traditional | Dantec Medical, Inc. | 09/16/1996SE |
More from Dantec Medical, Inc.
| 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 |
| K922476 | Uro-Pro 2000FAP · Traditional | 07/20/1993SE |
| 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 FST Cath Ud-Dual Dual Pressure Catheter cleared by the FDA?
FST Cath Ud-Dual Dual Pressure Catheter (K926088) received a 510(k) decision of Substantially Equivalent on June 18, 1993, 198 days after the submission was received.
What is the product code of K926088?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.