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www.fdanews.com/articles/210108-fda-clears-ionocare-to-remanufacture-robotic-scissors

FDA Clears Ionocare to Remanufacture Robotic Scissors

November 9, 2022

Ionocare has received 510(k) marketing clearance from the FDA to remanufacture and market a used DaVinci robotic surgical system attachment — 8 mm monopolar curved scissors for the EndoWrist Si system.

The monopolar scissors are for minimally invasive surgical procedures requiring the use of cutting. 

Encore Medical Device Repair, the organization working with Ionocare for marketing and distribution to hospitals, says that the remanufactured scissors can be used many more times after the remanufacturing process, saving hospitals hundreds of thousands of dollars. 

Encore sets up a collection system with hospitals for the used robotic attachment and makes loaner instruments available during the remanufacturing process.

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