WSP Code 4310 Stresscath
FDA 510(k) K850694 · Warne Surgical Products, Ltd.
510(k) numberK850694
Submission
- Device name
- WSP Code 4310 Stresscath
- Applicant
- Warne Surgical Products, Ltd.
Armagh Bt66 8rd, IE - Received
- February 21, 1985
- Decision date
- May 17, 1985
- 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 |
|---|---|---|
| K850696 | WSP Code 4300 Diomaster DiagnosticFAP · Traditional | 05/17/1985SE |
| K850695 | WSP Code 4301 Diomaster TherapeuticFAP · Traditional | 05/16/1985SE |
| K850693 | WSP Code 4315 PadtestFAP · Traditional | 05/10/1985SE |
| K841511 | Haematuria CathetersKOD · Traditional | 07/12/1984SE |
| K840687 | Kidney Transplant CatheterKDN · Traditional | 06/07/1984SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | 04/18/1984SE |
| K841411 | Rolled Neck W/PlugBTC · Traditional | 04/18/1984SE |
| K841410 | Bush Neck W/TapDRM · Traditional | 04/18/1984SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | 04/18/1984SE |
| K840704 | Secure W/35MM Diam, Sheath/AdhesiveKNX · Traditional | 03/22/1984SE |
Questions and answers
When was WSP Code 4310 Stresscath cleared by the FDA?
WSP Code 4310 Stresscath (K850694) received a 510(k) decision of Substantially Equivalent on May 17, 1985, 85 days after the submission was received.
What is the product code of K850694?
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.