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JustRight Surgical obtains FDA 510(k) approval for 5mm surgical stapler

JustRight Surgical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its JustRight 5mm stapler, designed for use by surgeons in pediatric and general surgery where access is limited and visibility is reduced.

JustRight Surgical claims that the JustRight 5mm stapler is the smallest classic stapler on the market. JustRight 5mm stapler is the third product from the company to obtain FDA approval since its founding in 2010.

The JustRight 5mm stapler has optimal jaw length for maneuverability into small spaces. The device is nine times smaller than existing stapling instruments in the market. The 5mm shaft diameter allows flexibility in stapler placement. It enables smooth and efficient stapling and cutting in one motion.

The 360 degree jaw rotation allows easy repositioning.

JustRight Surgical president and CEO Russ Lindemann noted the absence of innovation in this market is primarily due to minimal financial incentives for large companies to develop these micro instruments.

"As a result, pediatric surgeons are forced to use devices originally designed for adults. These instruments can be oversized, overpowered and difficult to maneuver in small patients and tight spaces. We felt it was critical to answer the call for smaller devices and expand the options available," Lindemann added.