Search Results

The wound drainage reservoir holder is to be used when the patent is using a Jackson-Pratt 100cc Suction Reservoir and would prefer to have the reservoir attached directly against his or her body instead of attaching it with a safety pin to one of the clothing garments they are wearing.

Wound Drainage Holder

The provided text is a 510(k) clearance letter from the FDA for a device called a "Wound Drainage Holder." This document does not contain any information regarding acceptance criteria, device performance, clinical study details, or ground truth establishment.

The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on a study proving the device's efficacy or meeting specific acceptance criteria.

Ask a specific question about this device