510(k) K931175 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
SCHUSTER DISPOSABLE BALLOON PROBE
| Applicant | Sandhill Scientific, Inc., Littleton CO, US |
| Decision | Substantially Equivalent, Apr 1, 1994 |
| Received | Mar 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.