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FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

FDA Grants De Novo to Claria Medical's Hysterectomy Tissue Extraction System

The authorization creates a new Class II device type for contained power morcellation of gynecologic tissue not suspected to be cancerous.

By News DeskJuly 13, 20262 min read
Three long-shafted laparoscopic surgical instruments with white handles laid on a blue cloth
Hand instruments used in laparoscopic surgery. Not the Claria System described in this article. ignis, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA De Novonew device type · DEN250034FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • The FDA granted De Novo request DEN250034 for the Claria System on July 2, 2026, classifying it in Class II under 21 CFR 884.4075; Claria announced it on July 13.
  • The device is indicated for contained cutting and extraction of tissue considered benign during laparoscopic hysterectomy, with limits for use in women with fibroids.
  • Claria says its study showed a median extraction time of four minutes for large uteri; it plans to present detailed data later this year.

The US Food and Drug Administration has granted De Novo marketing authorization to Claria Medical's Claria System, a device for containing and removing uterine tissue during laparoscopic hysterectomy, the Mountain View, California, company announced on July 13 in a release distributed by GlobeNewswire, read via BioSpace.

The FDA's decision letter, dated July 2, places the Claria System in Class II under a new regulation, 21 CFR 884.4075, with the generic name "gynecologic power morcellator and containment system." The agency received the De Novo request on August 7, 2025. The FDA's De Novo database lists the request as DEN250034, with product code SIM and review by the obstetrics and gynecology panel.

What the authorization covers

According to the letter, the system is indicated for contained cutting, coring and extraction of tissue during laparoscopic hysterectomy. Its container is introduced through the vagina to isolate and contain tissue "considered benign" while the Claria Bulk Tissue Reducer cuts it down for removal. When the system is used in women with fibroids, the indication is limited to women who are pre-menopausal and under age 50.

The new device type is defined as an integrated power morcellator and containment method intended for gynecologic tissue "that is not suspected to contain malignancy." The FDA's table of identified risks includes spread of tissue inside the abdomen, including occult cancer or fibroid fragments, from a breach of the containment, and vaginal wound problems or organ injury. The agency set special controls that include clinical and non-clinical performance testing, software verification, electrical, thermal and mechanical safety testing, labeling and training.

What the company says

Claria said the device was accepted into the FDA's Safer Technologies Program, which the company described as intended to speed review of devices expected to significantly improve the safety of current treatments. The company says the system is the first integrated tissue containment and removal system authorized by the FDA.

According to the release, the system's SafeStop technology uses electronic communication between a three-layer container and the handpiece to prevent unintended breaches of the barrier, and the transvaginal approach removes tissue without a mini-laparotomy. The company said a prospective, multinational, controlled clinical study supported the submission and showed a median extraction time of four minutes for large uteri. It has not yet published the study and said it intends to present detailed data later this year.

"The safety risks associated with today's standard of care are simply too high," said Claria Medical chief executive Alexey Salamini. The company said it is now finalizing arrangements for multiple commercial pilot sites with health systems around the country. It did not disclose pricing or a full launch date.

Sources

  1. FDA Grants De Novo Classification to Claria Medical for Device Designed to Improve Safety and Efficiency of Hysterectomy Procedures (GlobeNewswire, read via BioSpace), Claria Medical, July 13, 2026
  2. De Novo decision letter DEN250034: Claria System, US Food and Drug Administration, July 2, 2026
  3. De Novo database entry DEN250034: Claria System (page as updated 2026-10-26; facts cited were in the 2026-07-02 version), US Food and Drug Administration, July 2, 2026