# K983234: Tielle Plus Hydropolymer Adhesive Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
- Decided: Nov 25, 1998 after 71 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973688 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973688: Duoderm Control Gel Formula Border Dressing, Convatec, Ltd. (1997) Summary page 1.

## Indications for use
TIELLE*® PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily exuding wounds. The island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autotytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate. TIELLE® PLUS Hydropolymer Dressing is indicated for the management of chronic and acute, moderate to heavily exuding, partial and full thickness wounds including: s« Superficial wounds 1. Minor abrasions 2. Skin Tears 3. Second Degree Burns TIELLE* PLUS Hydropolymer Dressing should be used under health care professional directlon for the following indications: Pressure ulcers Lower extremity ulcers 1. Venous 2. Arterial 3. Mixed etiology Diabetic ulcers Donor sites TIELLE* PLUS Hydropolymer Dressing is suitable for use under compression bandaging. PRECAUTIONS TIELLE PLUS Dressing is not indicated for use on the following: o Third degree bums o Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional. TIELLE PLUS Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

Source page: https://510kreport.com/device/K983234
Methodology: https://510kreport.com/methodology