K931175 is an FDA 510(k) clearance for the SCHUSTER DISPOSABLE BALLOON PROBE, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on April 1, 1994, 388 days after receiving the submission on March 9, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K931175 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 1993 |
| Decision Date | April 01, 1994 |
| Days to Decision | 388 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1620 |