PADLOCK CLIP EFTR Kit (00713229)

The PADLOCK CLIP EFTR Kit is an electrosurgical device designed for flexible endoscopy to perform diagnostic tissue acquisition and full-thickness resection of lesions less than 3cm in the colon and rectum. The kit includes a preloaded nitinol clip delivery system, a snare for tissue resection, a TOUCHSOFT Coagulator for marking lesion perimeters, and a RAPTOR Grasping Device for tissue manipulation.

The proposed device has identical technological characteristics to the predicate K240274: same construction (molded handle, connector, clip actuator, clip housing, nitinol clip, stainless steel snare), same materials across all components, same sterilization method (ethylene oxide at 10-6 SAL), same dimensions (230cm length, 20mm cap outer diameter), same energy delivery (monopolar high frequency), and same MRI safety status (MR Conditional).

Not stated in this summary.

The submission is a labeling-only modification to an existing cleared device. The proposed and predicate devices are physically and functionally identical; the change consists solely of updated Instructions for Use. Verification testing demonstrated that the clip deploys and snare closes properly on simulated tissue, confirming that the revised labeling does not introduce new safety or effectiveness concerns. Therefore, the device performs identically to the legally cleared predicate K240274 under the same intended use.