Uroscan
FDA 510(k) K870855 · Endotherapeutics
510(k) numberK870855
Submission
- Device name
- Uroscan
- Applicant
- Endotherapeutics
Menlo Park, CA, US - Received
- March 3, 1987
- Decision date
- June 9, 1987
- 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 |
|---|---|---|
| K860192 | Endoport 5MM Single-Use Trocar and SleeveHET · Traditional | 03/17/1986SE |
| K860103 | Mod. Endoport Single-Use Trocar and SleeveGCP · Traditional | 02/12/1986SE |
| K860102 | Mod. Endoneedle Single-Use Pneumoperitoneum NeedleFHP · Traditional | 02/12/1986SE |
| K852031 | Endoport 5MMHET · Traditional | 08/13/1985SE |
| K844619 | EndoneedleFHO · Traditional | 01/09/1985SE |
| K841716 | Endoport ErocarFBQ · Traditional | 06/28/1984SE |
Questions and answers
When was Uroscan cleared by the FDA?
Uroscan (K870855) received a 510(k) decision of Substantially Equivalent on June 9, 1987, 98 days after the submission was received.
What is the product code of K870855?
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.