
Spectra Medical Devices
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Spectra Soft Tissue Biopsy Needles is an FDA 510(k)-cleared medical device (K142791) manufactured by Spectra Medical Devices. 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 January 20, 2015. Regulation: 8.