Ark Surgical, a women’s health-focused medical device company, has received FDA 510(k) clearance for LapBox POWER, a breakthrough tissue containment system (TCS) for use with power morcellators in minimally invasive gynecologic surgery.
This expanded indication builds on the company’s 2023 clearance for manual morcellation, making LapBox the first and only FDA-cleared dual-wall containment system for both manual and power tissue extraction.
Designed in collaboration with leading OB/GYNs, LapBox features an intuitive “bag-in-a-bag” structure that provides a spill-proof barrier – helping to prevent the spread of undiagnosed cancer, endometrial cells, and other potentially harmful tissues during laparoscopic procedures.
The TCS system integrates seamlessly into surgical workflows without adding complexity or time.
Stav Tori is CEO of Ark Surgical.
Tori said: “This new clearance validates what surgeons have already come to appreciate about LapBox – a reliable, intuitive system that raises the bar for safety without complicating the procedure.
“We are proud to deliver the only tissue containment solution cleared for both manual and power morcellation.”
Morcellation is a widely used technique in gynecologic surgery to remove large tissue masses like fibroids or the uterus through small incisions.
Yet uncontained morcellation carries risks, including spreading undiagnosed malignancies or endometrial cells that may worsen conditions like endometriosis or chronic pelvic pain.
In response, the FDA issued multiple safety communications beginning in 2014 and has since urged surgeons to use FDA-cleared containment systems.
With over 2.5 million gynecologic procedures performed annually worldwide and the laparoscopic GYN market projected to reach $61 billion by 2034, the need for effective, surgeon-friendly solutions has never been greater.
LapBox aims to tackle the problem, supporting safer, smarter surgeries that benefit both patients and providers.
