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ZipLine Medical noninvasive skin closure system approved by China Food and Drug Administration
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ZipLine Medical Inc. recently announced China Food and Drug Administration approval and the commercial availability of its Zip Surgical Skin Closure device in China.
According to a company press release, the noninvasive wound closure device replaces traditional sutures, staples and glue for surgical incisions. The clearance will give ZipLine Medical, which is based in Campbell, Calif., access to the $543 million Chinese wound closure market. The market includes specialties such as orthopedics, with potential application in total joint replacement.
“The noninvasive Zip closure is ideally suited for the health care market in China, in light of its large and growing procedure volume, need for cost-effective and efficient solutions, and appreciation of aesthetics,” John Tighe, president and chief executive officer of ZipLine Medical, said in the release. “We look forward to working with our team of distribution partners across China to bring the speed, safety, comfort and convenience of Zip to Chinese patients.”
In addition to the China Food and Drug Administration approval, Zip Surgical Skin Closure devices have received the CE mark and are classified by the U.S. FDA as class I 510(k) exempt devices.
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