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FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc

G.I. Windows, Inc. · Model 100027 · UDI-DI 00860012315536

SAH Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic access to implant the magnet (dipolar magnet B) and OTOLoc contained in the cartridge. This architecture allows the user to reload a new Cartridge onto the Handpiece for the deployment of additional Implants as required by the surgical procedure. The user attaches the cartridge onto the Handpiece, inserts it through a trocar for use. After the implants has been fully deployed, the user can remove the FlexFire Universal Delivery Tool from the trocar and either reload it with another Cartridge for additional magnet implant deployments or discard it at the end of the procedure.

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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.