Rusch Urodynamic Rectal Balloon 2-WAY Catheter
FDA 510(k) K962472 · Rusch Intl.
510(k) numberK962472
Submission
- Device name
- Rusch Urodynamic Rectal Balloon 2-WAY Catheter
- Applicant
- Rusch Intl.
Jeffrey, NH, US - Received
- June 25, 1996
- Decision date
- August 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| 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 |
|---|---|---|
| K033023 | Intermittent Urethral CathetersKOD · Traditional | 12/23/2003SE |
| K030559 | Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemESW · Traditional | 06/30/2003SE |
| K023666 | Rusch Guided Cholangiography CatheterFGE · Traditional | 06/17/2003SE |
| K023918 | Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessJOH · Traditional | 03/28/2003SE |
| K023964 | Rusch Microlaryngeal TubeBTR · Traditional | 12/23/2002SE |
| K021540 | Rusch Edgar TubeBTR · Traditional | 08/01/2002SE |
| K021764 | Rusch Tracheofix Set, Cuffed and UncuffedBTO · Traditional | 07/23/2002SE |
| K020714 | Rusch Floneil; Flocath IntrogelGBM · Traditional | 07/01/2002SE |
| K010798 | Rusch Cantor TubeKNT · Traditional | 02/26/2002SE |
| K010797 | Rusch Miller-Abbott TubeKNT · Traditional | 02/26/2002SE |
Questions and answers
When was Rusch Urodynamic Rectal Balloon 2-WAY Catheter cleared by the FDA?
Rusch Urodynamic Rectal Balloon 2-WAY Catheter (K962472) received a 510(k) decision of Substantially Equivalent on August 27, 1996, 63 days after the submission was received.
What is the product code of K962472?
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.