CO2 Cystoscopy/Urethroscopy Console
FDA 510(k) K800822 · Kli
510(k) numberK800822
Submission
- Device name
- CO2 Cystoscopy/Urethroscopy Console
- Applicant
- Kli
Mchenry, IL, US - Received
- April 14, 1980
- Decision date
- June 17, 1980
- 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 |
|---|---|---|
| K800913 | Gynecological Cysto/UrethroscopeFGC · Traditional | 05/14/1980SE |
| K781913 | Insuffalator LaparaoscopicHIF · Traditional | 12/04/1978SE |
| K781109 | Forceps, ElectrosurgicalHIN · Traditional | 09/14/1978SE |
| K781089 | One Incision Bi-Polar Electro. ForcepsHIN · Traditional | 07/17/1978SE |
| K780955 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K780954 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K772297 | Insufflator, Model G100 & 200HIF · Traditional | 01/05/1978SE |
| K772242 | Laparoscopy Console Model ViiiHET · Traditional | 12/20/1977SE |
| K772220 | Probe, Coagulation AccessoryKNF · Traditional | 12/13/1977SE |
| K772185 | Laparoscope W/Removable OpticsHET · Traditional | 11/30/1977SE |
Questions and answers
When was CO2 Cystoscopy/Urethroscopy Console cleared by the FDA?
CO2 Cystoscopy/Urethroscopy Console (K800822) received a 510(k) decision of Substantially Equivalent on June 17, 1980, 64 days after the submission was received.
What is the product code of K800822?
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.