K161785 is an FDA 510(k) clearance for the THD ANOPRESS. This device is classified as a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II - Special Controls, product code KLA).
Submitted by Thd Spa (Correggio, IT). The FDA issued a Cleared decision on March 14, 2017, 258 days after receiving the submission on June 29, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K161785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2016 |
| Decision Date | March 14, 2017 |
| Days to Decision | 258 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 |