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

THD SPA · Model THD Surgy Mini Light - Scope Sterile · UDI-DI 08033737710647

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

Description

The THD SURGY light-scope anoscope is a sterile and disposable medical device deemed for investigation of the anal canal. The THD SURGY light-scope anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The THD SURGY light-scope anoscope is ready-to-use and does not need for other tools.

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.