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GYRUS ACMI
Gyrus ACMI, LLC · Model 5700016 · UDI-DI 00821925010192
FGO
Prescription
10
510(k) clearances
315
Adverse events (1 deaths)
3
Recalls
29
Facilities
Description
SURLOK Helical Stone Basket 4.5 FR (1.5 mm) X 70 cm Basket width: 11 mm # of Wires: 6
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-11-14 | US Endoscopy Group Inc | When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become |
| 2003-06-30 | Scion Cardio-Vascular, Inc. | The firm received field complaints that it was difficult to open the stone retrieval basket during use. |
| 2003-05-23 | Scion Cardio-Vascular, Inc. | Possible difficulty for the user in opening the stone retrieval basket. |
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Get your free API keyRead the docsData 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.