K031617 is an FDA 510(k) clearance for the MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER, a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II — Special Controls, product code KLA), submitted by Mediplus , Ltd. (Potomac, US). The FDA issued a Cleared decision on January 16, 2004, 238 days after receiving the submission on May 23, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K031617 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 2003 |
| Decision Date | January 16, 2004 |
| Days to Decision | 238 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 |