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THD Anopress

THD SPA · Model THD Anopress · UDI-DI 18033737711245

KLA Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

THD Anopress is a portable system that allows the execution of the anal manometry in an easy and standardized way, by measuring the pressure data of the sphincterial cylinder in different phases: rest, squeeze, strain and endurance. THD Anopris practical and easy to use, compact, light and easily transportable. It is suitable for immediate use both in outpatient clinic and hospital. It is provided with a 3.5" color display that allows to visualize both the pressure values and the relevant curves. THD Anopress is operated by rechargeable batteries whose charge lasts approximately 5 hours. Through the Bluetooth connection, THD Anopress is able to register the exam over a dedicated software.

Recalls

Date	Firm	Reason
2006-04-06	Medtronic Gastroenterology / Urology	Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.