21 CFR 884.4075 — Gynecologic Power Morcellator And Containment System

Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4075

Identification

The Claria System is a prescription device indicated for contained cutting, coring, and extraction of tissue during laparoscopic hysterectomy. It consists of an integrated power morcellator and a containment method intended to contain, reduce, and remove gynecologic tissue that is not suspected to contain malignancy. 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 system is indicated for pre-menopausal women under age 50.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for Class II. Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes