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

THD SPA · Model THD Light-Scope_Rectoscope Large with inflation bulb_Sterile · UDI-DI 08033737710579

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

Description

The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The THD Light-Scope rectoscope combines a magnifier lens in the back cap. The handle has a lodgement for a THD Fiber Optic Cable tip for using the rectoscope with a THD light source. The THD Light-Scope rectoscope is ready-to-use and can also be available with an inflation bulb included.

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.