Urdyn 5000 (Uroflowmeter)
FDA 510(k) K860368 · Dantec Electronics, Inc.
510(k) numberK860368
Submission
- Device name
- Urdyn 5000 (Uroflowmeter)
- Applicant
- Dantec Electronics, Inc.
Allendale, NJ, US - Received
- February 3, 1986
- Decision date
- April 23, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFO – Retractor, Self-Retaining
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993544 | Space-Or RetractorFFO · Traditional | Advanced Surgical Concepts (Asc) | 12/22/1999SE |
| K870897 | Kodner Anal Perioneal RetractorFFO · Traditional | Sur-Med Instruments, Inc. | 06/04/1987SE |
| K853119 | Urodyn 1000FFO · Traditional | Dantec Electronics, Inc. | 10/04/1985SE |
| K852083 | The Kendall Urinary Output MonitorFFO · Traditional | The Kendal Co. | 09/20/1985SE |
More from The Kendal Co.
| 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 |
| K874759 | 13L81 Disposable Sphincter Electrode, 13L33 CableFAP · Traditional | 04/14/1988SE |
| 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 |
| K853119 | Urodyn 1000FFO · Traditional | 10/04/1985SE |
Questions and answers
When was Urdyn 5000 (Uroflowmeter) cleared by the FDA?
Urdyn 5000 (Uroflowmeter) (K860368) received a 510(k) decision of Substantially Equivalent on April 23, 1986, 79 days after the submission was received.
What is the product code of K860368?
The FDA product code is FFO – Retractor, Self-Retaining, a Class I (low risk) device regulated under 21 CFR 876.4730.