Deroyal - FDA 510(k) Cleared Devices

Deroyal, is a global medical device manufacturer founded in 1973, with a manufacturing facility in Knoxville, Tennessee. The company specializes in surgical textiles, patient care products, orthopedic devices, wound care solutions, and temperature management systems for healthcare providers worldwide.

Deroyal received 5 FDA 510(k) clearances from 5 total submissions between 2002 and 2004. The company's cleared devices span general hospital surgical products, including surgical gowns, drapes, and specialized catheters for gastroenterology and urology applications. The company is currently inactive with no FDA submissions recorded in the past two decades, making this a historical regulatory record.

Deroyal's cleared device portfolio included sterile and non-sterile surgical gowns, poly-reinforced surgical gowns, backtable covers, temperature-monitoring Foley catheters, and specialized surgical accessories. The company maintained a commitment to quality manufacturing and international distribution across over 70 countries.

For detailed information on specific device names, product codes, and clearance dates, consult the FDA 510(k) database or contact the company directly.