Search Results

Reloadable Cutters

The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.

Reloadable Staplers

The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.

The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.

The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.

The provided text is a 510(k) Summary for a medical device called "ClearMedical Reprocessed Reloadable Linear Cutters and Staplers" (K033579) and a subsequent FDA clearance letter for a related product with similar name (K033578). The documents essentially state that the reprocessed devices are substantially equivalent to their predicate devices. However, the text does NOT contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.

The 510(k) Summary states: "Validation of cleaning, performance, packaging, and sterilization together with biocompatibility testing demonstrate reprocessed clip reloadable cutters and staplers perform as intended and are safe and effective." This is a high-level statement and does not provide the specifics requested in your prompt.

Therefore, I cannot fill out the requested table and answer the study-related questions based on the provided input because the required detailed information is not present. The document focuses on establishing substantial equivalence based on the technological characteristics being unchanged and relying on general validation of various aspects rather than a specific comparative performance study with defined acceptance criteria and statistical analysis.

If this information were present, it would typically be found in dedicated sections detailing performance testing methodologies, results, and statistical analyses, which are absent here.

Ask a specific question about this device