Piper, Model Number Uds-Piperb
FDA 510(k) K951805 · Laborie Medical Technologies, Ltd.
510(k) numberK951805
Submission
- Device name
- Piper, Model Number Uds-Piperb
- Applicant
- Laborie Medical Technologies, Ltd.
Mississauga, CA - Received
- April 18, 1995
- Decision date
- July 6, 1995
- 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 |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | Medtronic Functional Diagnostics A/S | 02/28/2000SE |
| 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 |
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| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA · Traditional | 04/23/2024SE |
| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipFBK · Traditional | 07/21/2009SE |
| K082614 | Evox Electro Diagnostic DeviceGWF · Traditional | 03/06/2009SE |
| K081781 | NuwavIYO · Traditional | 07/09/2008SE |
| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | 03/05/2008SE |
| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | 05/04/2007SE |
| K962009 | UrostymKPI · Traditional | 05/20/1997SE |
| K955856 | Tex-Aid BlueLKY · Traditional | 02/16/1996SE |
Questions and answers
When was Piper, Model Number Uds-Piperb cleared by the FDA?
Piper, Model Number Uds-Piperb (K951805) received a 510(k) decision of Substantially Equivalent on July 6, 1995, 79 days after the submission was received.
What is the product code of K951805?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.