Who is the manufacturer of SURESKIN BORDER?

Euromed A/S filed the 510(k) submission for SURESKIN BORDER (K960393).

What is the FDA product code for SURESKIN BORDER?

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

What is the regulatory pathway for SURESKIN BORDER?

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

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

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 BORDER

K960393 · Euromed A/S · MGP · Mar 1, 1996 · SU

Device Facts

Record ID	K960393
Device Name	SURESKIN BORDER
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® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily 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 to wound site to maintain moist environment and manage exudate. Provides physical barrier.

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 tested per ISO 10993.

Indications for Use

Indicated for management of lightly to heavily exudating pressure sores and leg ulcers in patients requiring wound care.

Predicate Devices

DuoDerm Dressing (Convatec)

Related Devices

K960394 — SURESKIN STANDARD · Euromed A/S · Mar 1, 1996
K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 · Acutek Adhesive Specialties, Inc. · Oct 13, 1998
K971126 — HYDROCOLLOID WOUND DRESSINGS · Innovative Technologies , Ltd. · Jun 24, 1997
K974348 — ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING · Laboratoires Urgo S.A. · Feb 13, 1998
K983249 — SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN · Euromed, Inc. · Nov 25, 1998

Submission Summary (Full Text)

{0} K960393 # 510(k) SUMMARY ## SureSkin® BORDER 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® BORDER 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® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure 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, Euromed SureSkin™ BORDER 510(k) 1/25/96 Page D-1 19 {1} 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™ BORDER 510(k) 1/25/96 Page D-2 114