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Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.

Vanguard intends to market Reprocessed Disposable Cutters and Staplers, that have removable reloads. Vanguard reprocesses only the hand held instrument. All reloads are removed and discarded before being reprocessed. Reprocessing Cutters, Staplers and Appliers is performed according to Vanguard protocol Number 40018. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. (See FDA Guidance Document: Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). Vanguard is a "third party reprocessor" and reprocesses used single-used medical devices. Vanguard does NOT reprocess the re-loads. Reloads must be supplied by the hospital. Vanguard believes that single-use Cutters, Staplers and Appliers can be considered "reusable" - by Vanguard " as defined in the Food and Drug Administration Compliance Policy Guide #7124.16; they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Linear staplers deliver staggered rows of staples in order to approximate internal tissues. Linear Cutters are hand held surgical devices used to deliver staggered rows of staples while simultaneously dividing the tissue. Appliers are hand held surgical instruments that litigate tubular structures and vessels.

This document is a 510(k) summary for Vanguard Medical's reprocessed disposable cutters, staplers, and appliers. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document focuses on establishing substantial equivalence to legally marketed predicate devices rather than providing performance study details.

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