Who is the manufacturer of SURESKIN STANDARD?

Euromed A/S filed the 510(k) submission for SURESKIN STANDARD (K960394).

What is the FDA product code for SURESKIN STANDARD?

MGP. as a Class U device in the SU panel.

What is the regulatory pathway for SURESKIN STANDARD?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SURESKIN STANDARD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SURESKIN STANDARD

K960394 · Euromed A/S · MGP · Mar 1, 1996 · SU

Device Facts

Record ID	K960394
Device Name	SURESKIN STANDARD
Applicant	Euromed A/S
Product Code	MGP · SU
Decision Date	Mar 1, 1996
Decision	SN
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure sores and leg ulcers.

Device Story

Hydrocolloid wound dressing; consists of hydrocolloid contact layer and occlusive polyurethane backing; used for management of exudating pressure sores and leg ulcers; applied by clinicians or patients; provides moist wound environment; facilitates healing; protects wound site.

Clinical Evidence

Bench testing only; biocompatibility testing performed in conformance with Tripartite and ISO 10993 recommendations.

Technological Characteristics

Hydrocolloid material contact layer; occlusive polyurethane backing; biocompatibility per ISO 10993.

Indications for Use

Indicated for patients with light to heavy exudating pressure sores and leg ulcers.

Predicate Devices

DuoDerm Dressing (Convatec)

Related Devices

K960393 — SURESKIN BORDER · Euromed A/S · Mar 1, 1996
K971126 — HYDROCOLLOID WOUND DRESSINGS · Innovative Technologies , Ltd. · Jun 24, 1997
K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 · Acutek Adhesive Specialties, Inc. · Oct 13, 1998
K974348 — ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING · Laboratoires Urgo S.A. · Feb 13, 1998
K965143 — OSMOCYTE WOUND MANAGER SHEET DRESSING · Procyte Corp. · May 22, 1997

Submission Summary (Full Text)

{0} 510(k) SUMMARY K 960394 SureSkin® STANDARD Hydrocolloid Wound Dressing 1. DATE PREPARED January 25, 1996 2. SUBMITTER Euromed A/S Borgergade 6 DK-1300 Copenhagen Denmark 3. CONTACT Mr. Carsten Fredsbo General Manager Phone: 011-45-3316-3040 4. DEVICE NAME SureSkin® STANDARD Hydrocolloid Wound Dressing 5. DEVICE CLASSIFICATION Wound Dressings have not been finally classified by FDA. [Proposed Class I (21 CFR 878.4022)] Product Code: 79 MGP 6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure Euromed SureSkin™ STANDARD 510(k) 1/25/96 Page D-1 {1} sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDerm Dressing marketed by Convatec. Determination of substantial equivalence for this product was based on descriptive information about the design, materials, and intended use of the device. Biocompatibility testing was performed on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all biocompatibility tests demonstrated that the device is suitable for its intended use. Euromed SureSkin™ STANDARD 510(k) 1/25/96 Page D-2 13