Ark Surgical Secures FDA Clearance for LapBox® POWER, First Dual-Wall System for Contained Morcellation
- Ark Surgical
- May 16
- 2 min read
Expanded clearance positions Ark Surgical at the forefront of gynecologic safety amid FDA calls for safer morcellation.
TEL AVIV, Israel, April 22, 2025 /PRNewswire/ -- Ark Surgical, a women's health-focused medical device innovator, 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.
"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," said Stav Tori, CEO of Ark Surgical. "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® answers that call – supporting safer, smarter surgeries that benefit both patients and providers.
About Ark Surgical
Ark Surgical is a women's health-focused medtech company developing advanced tissue containment solutions for minimally invasive gynecologic surgery. Its flagship product, LapBox®, is the first and only FDA-cleared dual-wall system for both manual and power morcellation.
