Contrario Medical Receives FDA Clearance for Cyperus

Contrario Medical, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for Cyperus, its sperm separation device. Newswise and PR Newswire reported the announcement under the same headline.

FDA 510(k) clearance for Cyperus

According to Newswise, Cyperus is a sterile, single-use device that prepares motile sperm from semen. The reported clearance applies to a device intended for use in assisted reproduction procedures.

Newswise identified Contrario Medical as a Houston-based medical device company developing next-generation sperm separation technology. The company’s announcement centers on the FDA’s 510(k) clearance for Cyperus.

Reported applications in assisted reproduction

Newswise reported that Cyperus prepares motile sperm from semen for use in in vitro fertilization, intracytoplasmic sperm injection and intrauterine insemination. These applications are also listed in the company announcement carried by PR Newswire.

The reports describe Cyperus as a sperm separation device with a sterile, single-use format. The FDA clearance is the central regulatory event described by both publishers.

Key details from the announcement

• Company: Contrario Medical, Inc.
• Device: Cyperus sperm separation device.
• Regulatory event: FDA 510(k) clearance.
• Device format: Sterile and single-use.
• Reported uses: In vitro fertilization, intracytoplasmic sperm injection and intrauterine insemination.

What the reports establish

Newswise and PR Newswire identify Contrario Medical’s FDA 510(k) clearance as the reported event. Newswise further states that the device prepares motile sperm from semen, while naming IVF, ICSI and IUI as its stated uses.

For medical device professionals following reproductive-health technologies, the announcement adds a cleared sperm separation device to the set of products described by the publishers for assisted reproduction procedures.