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THD PressProbe

THD SPA · Model THD PressProbe (Env) · UDI-DI 08033737711286

KLA Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination. Each pack contains a proprietary Probe Card, to enable the recording of the examination.

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.