Company ยท US
Sandhill Scientific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2011. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2011 | K111013 | ACEM Sandhill Scientific, Inc. | FFZ |
| Jun 7, 2002 | K012232 | INSIGHT, MODEL S980000 Sandhill Scientific, Inc. | FFX |
| Feb 28, 2002 | K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE Sandhill Scientific, Inc. | FFT |
| Jun 22, 2001 | K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 Sandhill Scientific, Inc. | FFX |
| May 12, 1999 | K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 Sandhill Scientific, Inc. | FFX |
| Jan 11, 1999 | K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 Sandhill Scientific, Inc. | FFX |
| Jun 6, 1996 | K961056 | BIOVIEW MODEL S960000 Sandhill Scientific, Inc. | KLA |
| Apr 9, 1996 | K942247 | SMALL BOWEL ANALYSIS SOFTWARE Sandhill Scientific, Inc. | FFX |
| Sep 8, 1995 | K941801 | ANALGRAPH Sandhill Scientific, Inc. | KLA |
| Sep 28, 1994 | K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE Sandhill Scientific, Inc. | FFT |
| Aug 26, 1994 | K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) Sandhill Scientific, Inc. | HIR |
| Apr 1, 1994 | K932306 | MICROINFUSOR Sandhill Scientific, Inc. | FFX |
| Apr 1, 1994 | K931175 | SCHUSTER DISPOSABLE BALLOON PROBE Sandhill Scientific, Inc. | FAP |
| Feb 7, 1992 | K912772 | SUPERLOGGER Sandhill Scientific, Inc. | FFT |
| Jan 2, 1991 | K904231 | MODEL OSP, SANDHILL AMS Sandhill Scientific, Inc. | FAD |
| Feb 21, 1984 | K834512 | SANDMILL RMS Sandhill Scientific, Inc. | FFT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2012 | Sandhill Scientific, Inc Insight rev H software.
The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal stud Terminated |
FFX | K012232 |
| Jan 6, 2006 | Sandhill Scientific, Inc Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured Terminated |
FAP | None listed |
| Jan 6, 2006 | Sandhill Scientific, Inc Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products. Terminated |
FAP | K931175 |
| Jan 6, 2006 | Sandhill Scientific, Inc Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured Terminated |
FAP | K931175 |
| Nov 11, 2003 | Sandhill Scientific, Inc ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system Terminated |
FFT | K931963 |
| Jan 23, 2003 | Sandhill Scientific, Inc ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually. Terminated |
FFT | K931963 |