# DEN250034: Claria System

- Pathway: De Novo (Direct)
- Applicant: Claria Medical, Inc.
- Decided: Jul 2, 2026 after 329 days
- Product code: SIM (Gynecologic Power Morcellator And Containment System)
- Device class: 2
- Regulation: 21 CFR 884.4075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Claria System is indicated for contained cutting, coring, and extraction of tissue during laparoscopic hysterectomy. The Claria Container is introduced transvaginally to isolate and contain tissue considered benign during powered bulk tissue reduction with the Claria Bulk Tissue Reducer. When used in women with fibroids, the Claria System is for women who are pre-menopausal and under age 50.

Source page: https://510kreport.com/device/DEN250034
Methodology: https://510kreport.com/methodology