Microinfusor
FDA 510(k) K932306 · Sandhill Scientific, Inc.
510(k) numberK932306
Submission
- Device name
- Microinfusor
- Applicant
- Sandhill Scientific, Inc.
Littleton, CO, US - Received
- May 11, 1993
- Decision date
- April 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K111013 | AcemFFZ · Traditional | 12/19/2011SE |
| K012232 | Insight, Model S980000FFX · Traditional | 06/07/2002SE |
| K013951 | Sandhill Scientific Pediatec PH ProbeFFT · Traditional | 02/28/2002SE |
| K002427 | Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026FFX · Abbreviated | 06/22/2001SE |
| K990441 | Insight Sphincter of Oddi Manometry Module, Model S981300FFX · Traditional | 05/12/1999SE |
| K984444 | Insight Gastrointestinal Motility System, Model S980000FFX · Special | 01/11/1999SE |
| K961056 | Bioview Model S960000KLA · Traditional | 06/06/1996SE |
| K942247 | Small Bowel Analysis SoftwareFFX · Traditional | 04/09/1996SE |
| K941801 | AnalgraphKLA · Traditional | 09/08/1995SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | 09/28/1994SE |
Questions and answers
When was Microinfusor cleared by the FDA?
Microinfusor (K932306) received a 510(k) decision of Substantially Equivalent on April 1, 1994, 325 days after the submission was received.
What is the product code of K932306?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.