Who is the manufacturer of TIELLE HYDROPOLYMER FOAM DRESSING?

Johnson & Johnson Medical, Inc. filed the 510(k) submission for TIELLE HYDROPOLYMER FOAM DRESSING (K964016).

What is the FDA product code for TIELLE HYDROPOLYMER FOAM DRESSING?

KMF. It is classified under 21 CFR 880.5090 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for TIELLE HYDROPOLYMER FOAM DRESSING?

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

What are the predicate devices for TIELLE HYDROPOLYMER FOAM DRESSING?

Allevyn Hydrophilic Polyurethane Dressing (Smith & Nephew).

Who can help prepare an FDA 510(k) submission like TIELLE HYDROPOLYMER FOAM DRESSING?

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.

TIELLE HYDROPOLYMER FOAM DRESSING

K964016 · Johnson & Johnson Medical, Inc. · KMF · Dec 31, 1996 · General Hospital

Device Facts

Record ID	K964016
Device Name	TIELLE HYDROPOLYMER FOAM DRESSING
Applicant	Johnson & Johnson Medical, Inc.
Product Code	KMF · General Hospital
Decision Date	Dec 31, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 880.5090
Device Class	Class 1
Attributes	Therapeutic

Intended Use

TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: - Pressure sores (all stages) - Venous ulcers - Skin tears - Second degree burns - Donor and graft sites - Acute wounds healing by secondary or primary intention - Surgically debrided wounds

Device Story

TIELLE Hydropolymer Foam Dressing; hydrophilic polyurethane polymer wound dressing; manages moderate to heavily exudating chronic and superficial wounds; applied topically to wound site; absorbs exudate; maintains moist wound environment; used in clinical or home settings; applied by healthcare professionals or patients; facilitates healing of pressure sores, venous ulcers, burns, and surgical wounds.

Clinical Evidence

Bench testing only. Biocompatibility testing confirms device is non-sensitizing and non-irritating.

Technological Characteristics

Hydrophilic polyurethane polymer foam dressing. Material properties support exudate absorption and moisture management. No electronic, software, or energy-based components.

Indications for Use

Indicated for management of chronic and superficial, moderate to heavily exudating wounds in patients with pressure sores, venous ulcers, skin tears, second degree burns, donor/graft sites, acute wounds healing by primary/secondary intention, and surgically debrided wounds.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

Allevyn Hydrophilic Polyurethane Dressing (Smith & Nephew)

Related Devices

K983394 — MODIFICATION TO TIELLE HYDROPOLMER DRESSING · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 3, 1998
K983234 — TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 25, 1998
K971126 — HYDROCOLLOID WOUND DRESSINGS · Innovative Technologies , Ltd. · Jun 24, 1997
K961662 — ADVANCED CARE HYDROPHILIC WOUND DRESSINGS · Mariner Biomedical, Inc. · Jun 13, 1996
K121361 — CURALINE POLYURETHANE FOAM AWC DRESSING · Curaline, Inc. · Nov 30, 2012

Submission Summary (Full Text)

{0} DEC 24. 1996 10:00AM K964016 # 510(k) SUMMARY ## TIELLE* Hydropolymer Foam Dressing DEC 31 1996 1. **DATE PREPARED** December 24, 1996 2. **SUBMITTER** Johnson & Johnson Medical, Inc. 2500 Arbrook Boulevard, P.O. Box 90130 Arlington, Texas 76004-3130 3. **CONTACT** Ralph H. Larsen, (817)784-4993 Sr. Project Manager, Regulatory Affairs 4. **NAME OF THE MEDICAL DEVICE** Classification name: Dressing, wound Common/usual name: Topical wound dressing Proprietary name: TIELLE* Hydropolymer Foam Dressing 5. **DEVICE CLASSIFICATION** Classification for topical wound dressings has not yet been finalized by the Division of Surgical and Rehabilitation Devices. These devices are classified into Class I (General Controls). 6. **STATEMENT OF SUBSTANTIAL EQUIVALENCE** TIELLE* Hydropolymer Foam Dressing is substantially equivalent and identical in function to Allevyn Hydrophilic Polyurethane Dressing marketed by Smith & Nephew. 7. **INDICATIONS FOR USE** TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: - Pressure sores (all stages) - Venous ulcers - Skin tears - Second degree burns - Donor and graft sites - Acute wounds healing by secondary or primary intention - Surgically debrided wounds 8. **PHYSICAL DESCRIPTION** TIELLE* Hydropolymer Foam Dressing is made from a hydrophilic polyurethane polymer. 9. **BIOCOMPATIBILITY** {1} DEC. 24. 1990 10.03AM K464016 Safety tests demonstrate that TIELLE* Hydropolymer Foam Dressing is non-sensitizing, and non-irritating and suitable for its intended use.