K901125 is an FDA 510(k) clearance for the PROVOCATIVE SENSITIVITY BALLOON. This device is classified as a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II - Special Controls, product code KLA).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 25, 1991, 319 days after receiving the submission on March 12, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K901125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1990 |
| Decision Date | January 25, 1991 |
| Days to Decision | 319 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |