Monday February 17, 2014 0 commentsBOULDER - JustRight Surgical, a micro-laparoscopic medical device company focused on miniaturizing surgical instruments, announced it has received 510 (k) clearance from the U.S. FDA for its JustRight 5mm Stapler.
The stapler is the smallest classic stapler on the market, according to JustRight, and can be used by pediatric and general surgery doctors where access is limited and visibility is reduced.
The stapler is JustRight's third product to win FDA approval since its founding in 2010. The company is privately held by local investors who have provided more than $15 million in contributions over the last two years.
JustRight said the stapler is a "major step forward" for the pediatric market.
"The needs of our smallest patients are unique, yet the surgical tools available to surgeons for these cases are virtually non-existent," said Dr. Steve Rothenberg, JustRight's co-founder and medical advisor.
"In the electronics industry, miniaturization happens almost faster than we can absorb the changes. Meanwhile, the downsizing of surgical instrumentation has remained stagnant and we have made it our mission to change that."
JustRight said its new stapler is nine times smaller than existing stapling instruments.
"The absence of innovation in this market is primarily due to minimal financial incentives for large companies to develop these micro instruments," said Russ Lindemann, JustRight's president and CEO.
"We felt it was critical to answer the call for smaller devices and expand the options available."