THD Anopress with THD SensyProbe
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Thd Spa
Identifiers
- 510(k) Number
- K180135 FDA 510(k)
- FDA Product Code
- KLA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1725 FDA 510(k)
- Regulation Number
- 876.1725 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The THD Anopress with THD SensyProbe is a Monitor, Esophageal Motility, Anorectal Motility, and Tube device, designed for clinical anorectal manometry. It combines a manometer system with single-use probes—specifically the THD PressProbe and THD SensyProbe—to evaluate sphincter function, including resting tone, squeeze pressure, and strain responses, as well as recto-anal inhibitory reflex (RAIR) and rectal sensitivity.
The system is intended for use in gastroenterology and urology settings, featuring single-use, atraumatic probes with ergonomic handles to minimize patient discomfort. Supplied sterile and intended for single-use, the device operates under FDA 510(k) clearance (K180135) and MDR authorization. It is classified as a Class II medical device (876.1725) and includes multiple registration numbers for regulatory tracking.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: THD® Anopress for clinical anorectal manometry - THDLAB, THD SensyProbe THD SensyProbe is an innovative… - FDA.report, THD Anopress: portable solution for Clinical Anorectal Manometry | THD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180135 | Class II | Active |
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Manufacturer
- Manufacturer
- Thd Spa
Sources (2)
- FDA 510(k) K180135 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026