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THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope

THD SPA · Model THD Light - Scope Bevelled Anoscope Sterile · UDI-DI 08033737710548

FERGCP Prescription
10
510(k) clearances
86
Adverse events
1
Recalls
46
Facilities

Description

THD Light-Scope anoscope is a disposable medical device deemed for investigation of the anal canal. The handle has a lodgment for a THD Fiber Optic Cable tip for using the anoscope with a THD light source. The THD Light-Scope anoscope has a flat white end which allows to reflect the light and have a clear and detailed vision of the inspected field. The THD Light-Scope anoscope can be available with truncated or bevelled tip.

Recalls

DateFirmReason
2018-12-12Applied Medical Resources CorpUnintentional shifting of the tip insulation of the firm's electrosurgical probes.

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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.