
FUJIFILM Healthcare Americas Corporation
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Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is an FDA 510(k)-cleared medical device (K230752) manufactured by FUJIFILM Healthcare Americas Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2023. Regulation: 8.