Laborie Fiberoptic Pressure Sensor & Interface
FDA 510(k) K853059 · Tridak Division of Indicon, Inc.
510(k) numberK853059
Submission
- Device name
- Laborie Fiberoptic Pressure Sensor & Interface
- Applicant
- Tridak Division of Indicon, Inc.
Pearl River, NY, US - Received
- July 19, 1985
- Decision date
- January 10, 1986
- 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
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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 |
|---|---|---|
| K891007 | Nonimplanted Electrical Continence DeviceKPI · Traditional | 06/07/1990SE |
| K860744 | Opthalmic Surgical InstrumentsHMX · Traditional | 03/31/1986SE |
| K852856 | Laborie Urodynamics ProcessorFAP · Traditional | 10/17/1985SE |
| K851934 | Cytological Cervical Spatula the Multi-SpatulaHHT · Traditional | 07/05/1985SE |
| K842609 | R.L. Medical Twin Light SourceFCW · Traditional | 08/09/1984SE |
| K840605 | Laborie Fibreoptic Light CableFFS · Traditional | 04/13/1984SE |
Questions and answers
When was Laborie Fiberoptic Pressure Sensor & Interface cleared by the FDA?
Laborie Fiberoptic Pressure Sensor & Interface (K853059) received a 510(k) decision of Substantially Equivalent on January 10, 1986, 175 days after the submission was received.
What is the product code of K853059?
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.