Nicki, Model Number USD-NK-UP1
FDA 510(k) K924086 · Laborie Medical Technologies, Ltd.
510(k) numberK924086
Submission
- Device name
- Nicki, Model Number USD-NK-UP1
- Applicant
- Laborie Medical Technologies, Ltd.
North Attleboro, MA, US - Received
- August 13, 1992
- Decision date
- October 20, 1992
- 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
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|---|---|---|---|
| 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 |
| K922476 | Uro-Pro 2000FAP · Traditional | Fiberoptic Sensor Technlogies, Inc. | 07/20/1993SE |
| 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 |
More from R.L. Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | 08/27/2024SE |
| K240007 | Solar Compact (G4-1)FFX · Traditional | 05/06/2024SE |
| 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 Nicki, Model Number USD-NK-UP1 cleared by the FDA?
Nicki, Model Number USD-NK-UP1 (K924086) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 68 days after the submission was received.
What is the product code of K924086?
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.