13L81 Disposable Sphincter Electrode, 13L33 Cable
FDA 510(k) K874759 · Dantec Electronics, Inc.
510(k) numberK874759
Submission
- Device name
- 13L81 Disposable Sphincter Electrode, 13L33 Cable
- Applicant
- Dantec Electronics, Inc.
Allendale, NJ, US - Received
- November 18, 1987
- Decision date
- April 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
|---|---|---|
| K895460 | Concentric Electrode Type #13R01, 13R02IKT · Traditional | 06/18/1990SE |
| K894911 | Sensory Needle Electrode Dne 111-115,116-117,118GXZ · Traditional | 05/14/1990SE |
| K884915 | Dantec 22K60/61/62 Catheter Tip TransducerFAP · Traditional | 10/04/1989SE |
| K881915 | Dantec Magnetic StimulatorGWF · Traditional | 10/17/1988SE |
| K874758 | Dantec 13L40 St. Marks's Pudendal ElectrodeFAP · Traditional | 04/14/1988SE |
| K874735 | Dantec 13L35/36/37 Stim. and Recording ElectrodeGXY · Traditional | 01/22/1988SE |
| K870567 | Evoport 300GWF · Traditional | 10/06/1987SE |
| K872106 | Dantec CounterpointGWF · Traditional | 09/10/1987SE |
| K860368 | Urdyn 5000 (Uroflowmeter)FFO · Traditional | 04/23/1986SE |
| K853119 | Urodyn 1000FFO · Traditional | 10/04/1985SE |
Questions and answers
When was 13L81 Disposable Sphincter Electrode, 13L33 Cable cleared by the FDA?
13L81 Disposable Sphincter Electrode, 13L33 Cable (K874759) received a 510(k) decision of Substantially Equivalent on April 14, 1988, 148 days after the submission was received.
What is the product code of K874759?
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.