Who is the manufacturer of SURESKIN THIN?

Euromed A/S filed the 510(k) submission for SURESKIN THIN (K960404).

What is the FDA product code for SURESKIN THIN?

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

What is the regulatory pathway for SURESKIN THIN?

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

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

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 THIN

K960404 · Euromed A/S · MGP · Mar 1, 1996 · SU

Device Facts

Record ID	K960404
Device Name	SURESKIN THIN
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® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions.

Device Story

SureSkin® THIN Hydrocolloid Wound Dressing; sterile, occlusive dressing for wound management. Composed of hydrocolloid contact layer and polyurethane film backing. Used in clinical or home settings by patients or healthcare providers. Provides moist wound environment to facilitate healing; protects wound from external contaminants. Applied topically to dry to lightly exudating wounds; post-operative sites; superficial wounds; abrasions. Benefits include protection and maintenance of optimal healing conditions.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in conformance with Tripartite and ISO 10993 recommendations; results demonstrate suitability for intended use.

Technological Characteristics

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

Indications for Use

Indicated for management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions in patients requiring wound care.

Predicate Devices

DuoDERM Extra Thin Flexible Hydrocolloid Dressing

Related Devices

K974348 — ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING · Laboratoires Urgo S.A. · Feb 13, 1998
K992363 — SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN · Euromed, Inc. · Aug 12, 1999
K983249 — SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN · Euromed, Inc. · Nov 25, 1998
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

Submission Summary (Full Text)

{0} 510(k) SUMMARY SureSkin® THIN Hydrocolloid Wound Dressing K960404 # 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® THIN 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® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane. Euromed SureSkin™ THIN 510(k) 1/25/96 Page D-1 {1} film backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDERM Extra Thin Flexible Hydrocolloid Dressing. 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™ THIN 510(k) 1/25/96 Page D-2 1/2