FDA granted Claria Medical's De Novo request for the Claria System on July 2. The grant, DEN250034, creates a new regulation at 21 CFR 884.4075 for a gynecologic power morcellator and containment system, product code SIM. FDA received the request on August 7, 2025; the review took 329 days. The company announced the decision on July 13.
The Claria System extracts an enlarged uterus vaginally, inside a container, with no mini-laparotomy. It combines lighting, a blade and a large-bore handpiece with redundant safeguards against container breach. The company says contained morcellation today can take up to 90 minutes, with reported breach rates as high as 40%. In its prospective, multinational controlled study, the median extraction time for large uteri was four minutes. Full data are promised later this year.
Claria has been funded by National Science Foundation and National Institutes of Health grants plus private and strategic investors. It has not announced a priced round. CEO Alexey Salamini said commercial pilot sites with several health systems are being finalized. A grant-funded De Novo in under 11 months is a workable template for a single-product surgical startup. The pilot sites are where the four-minute figure has to hold up.