FDA Clears Allotrope’s Pelvic Operation Tool

November 19, 2020

The FDA has handed Allotrope 510(k) clearance for StimSite, an electrical stimulation device that helps identify ureters during pelvic surgeries.

The device helps obstetrician-gynecologists and surgeons locate the ureter, the duct that carries urine from the kidney to the bladder, during operations that include hysterectomies and colon resections.

The tool provides electrical stimulation to ureter smooth-muscle tissue to help find the duct, and it is able to connect to existing laparoscopic and robotic instruments and electrosurgical generators.

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