K013704 is an FDA 510(k) clearance for the MEDIPLUS SINGLE USE GI MANOMETRY CATHETER. This device is classified as a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II - Special Controls, product code KLA).
Submitted by Mediplus , Ltd. (St. Petersburg, US). The FDA issued a Cleared decision on August 5, 2002, 270 days after receiving the submission on November 8, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K013704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2001 |
| Decision Date | August 05, 2002 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |