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Self-light anoscopes

SAPI MED SPA · Model Operative Self-Led-Light · UDI-DI 08033638800478

FER
1
510(k) clearances
86
Adverse events
1
Recalls
46
Facilities

Description

SELF-LED-LIGHT - Surgical/Examination flute beaked proctoscope with built-in LED light. Disposable. Tube length 88mm. Tube diameter 23mm.

Recalls

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

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.