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Claria Medical secures FDA De Novo classification for hysterectomy device
Claria Medical has secured De Novo classification and marketing authorisation from the US FDA for its Claria System, a device designed to support tissue extraction during minimally invasive hysterectomy procedures. Regulatory submission for the device was supported by a multinational, prospective, controlled clinical study. The Claria system allows for transvaginal tissue extraction, avoiding mini-laparotomy. Credit: megaflopp / Shutterstock.com. Claria Medical has secured De Novo classification and marketing authorisation from the US Food and Drug Administration (FDA) for its Claria system, which is designed to support tissue extraction during minimally invasive hysterectomy procedures. The FDA reviewed the device under its Safer…
Claria Medical has secured De Novo classification and marketing authorisation from the US FDA for its Claria System, a device designed to support tissue extraction during minimally invasive hysterectomy procedures.
Source: Medical Device Network