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Self-light anoscopes

SAPI MED SPA · Model SELF-LIGHT SCOPE · UDI-DI 08033638800430

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

Description

SELF-LIGHT SCOPE - Surgical/Examination trunk ended proctoscope. Disposable. Tube length 79mm. Tube diameter 23mm (every 50 pcs. 1 pen-light free).

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.