Healthcare Industry News: reprocessing
News Release - May 22, 2006
SureTek Medical Receives Four Clearances from FDA Office of Device EvaluationGREENVILLE, SC, May 22, 2006 --(HSMN NewsFeed)--SureTek Medical announces that it has received four new premarket clearances this past week from FDA’s Office of Device Evaluation. These clearances allow the company to proceed to market with its reprocessing services for arthroscopic shavers and burs; electrosurgical electrodes; laparoscopic monopolar and bipolar instruments; and foot and leg compression sleeves.
“These new product lines allow us to offer a fuller range of services to surgical centers who wish to reduce their procedure costs and medical waste while maintaining a high standard for delivery of healthcare,” said SureTek CEO and President, Mike Sammon, Ph.D. “The 510(k)’s cover every major manufacturer of these medical devices, including Ethicon, U.S. Surgical, Arthrocare, Smith & Nephew, Gyrus Medical, Medtronic Xomed, ConMed/Linvatec, Stryker, Kendall and Huntleigh Healthcare.”
SureTek Medical is a privately held company that opened its Greenville, SC facility in January, 2006. The company provides resource management services to hand, arthroscopic, laparoscopic and ENT surgical centers, including reprocessing, refurbishing, packaging and sterilization of single-use devices. All SureTek products undergo rigorous validation testing in accordance with ISO, AAMI and ASTM standards for medical devices and FDA current Good Manufacturing Practices/Quality System Requirements.
Source: SureTek Medical
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