Seal the Uterine Tissue Before Removal: FDA Clears Claria’s Integrated Morcellation System for Marketing

Although minimally invasive hysterectomy uses small incisions, safely removing a larger uterus from the body can still be one of the most challenging parts of the procedure. The U.S. Food and Drug Administration (FDA) has authorized the marketing of Claria Medical’s integrated tissue containment and extraction system through the De Novo pathway, establishing a new Class II medical device classification for this type of device.

FDA records show that the Claria System’s submission number is DEN250034. It was submitted on August 7, 2025, and authorized on July 2, 2026. The agency classified it as a “gynecologic powered morcellator and containment system,” with product code SIM, subject to 21 CFR 884.4075, and restricted to prescription use by a physician.

The system is intended to contain, reduce, and remove gynecologic tissue not suspected of containing malignancy during minimally invasive surgery. According to the company, the device encloses the tissue in a three-layer containment bag, processes it using a powered handheld device, and uses an electronic communication mechanism to stop operation when the safety barrier may be compromised. The tissue is ultimately removed through the vagina, potentially reducing the need for an additional small incision to extract a large uterus.

The evidence supporting the application comes from a prospective, multinational, controlled clinical study. Claria said the median tissue extraction time for large uteri was four minutes and that operators required limited training. However, currently available information does not specify the number of participants, the control method, the containment-bag failure rate, adverse events, or how the four minutes were calculated. The company expects to publish the full results at a later date, so it is not yet possible to independently determine whether the speed advantage can be replicated across different hospitals and surgical settings.

Powered morcellation allows larger tissue to pass through minimally invasive incisions, but it also raises concerns about the spread of tissue fragments, damage to containment devices, and the inadvertent processing of an unidentified malignancy. The FDA-authorized indication explicitly excludes tissue suspected of being malignant, meaning the authorization does not eliminate the importance of preoperative assessment and patient selection. Whether the integrated containment design can further reduce the associated risks in routine use will depend on full trial data and postmarket experience.

The significance of the De Novo authorization extends beyond bringing a single product to market: it also establishes a regulatory framework for a novel type of medical device that previously lacked an existing classification. Claria is planning commercial pilots across multiple U.S. healthcare systems. The next key steps will be to transparently disclose the clinical study design and safety results and demonstrate that the device can maintain containment integrity and process efficiency when used by different surgical teams.