FDA Device Intelligence
HomeGyrus ACMI, LLC › USA Elite

USA Elite

Gyrus ACMI, LLC · Model REXERIS-CF25 · UDI-DI 00821925011014

FEC Prescription
1
510(k) clearances
44
Adverse events (1 deaths)
0
Recalls
13
Facilities

Description

USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr (8.5 mm), Color Coded Gold

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.