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THD PressKit

THD SPA · Model THD PressKit (FL ENV) · UDI-DI 08033737711309

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510(k) clearances

Adverse events

Recalls

Facilities

Description

THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) and an anoscope (THD n-Ano) that, in combination with the THD Anopress allows a handy and safely execution of the THD Anal manometry. 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. THD n-ano is a compact and manageable anoscope with an integrated LED light, completely disposable and packed individually. The reduced diameter and the atraumatic profile make the anoscope the ideal tool for a comfortable examination for both doctor and patient.

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.