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The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers.

The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers. The devices were originally cleared for marketing under K960393-SureSkin™ BORDER Dressing, K960394-SureSkin™ STANDARD Dressing, and K960404-SureSkin™ THIN Dressing. The only purpose of the current 510(k) premarket notification for these products is to update the device labeling to be consistent with equivalent products. The three dressings will be contraindicated for use on 3rd degree burns. No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission.

This document is a 510(k) summary for a labeling revision of SureSkin™ Hydrocolloid Wound Dressings. It explicitly states that "No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission."

Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria for the current submission. The submission focuses solely on updating device labeling, specifically contraindicating the dressings for 3rd-degree burns.

Consequently, I cannot provide the requested information in the table or answer questions 2 through 9, as they pertain to performance studies that were not conducted or included in this specific 510(k) submission.

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