# K173005: SURECELL Gelling Fiber Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Newvalue Medical Producst Co.,Ltd
- Decided: May 25, 2018 after 240 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 6 generations back to K914575 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070175: Aquanova Super-Absorbent Gelling Dressing, Otc, Medtrade Products, Ltd. (2007) Summary page 5.

## Indications for use
Under professional medical care, SURECELL Gelling Fiber Wound Dressing may be used for the management of : Leg ulcers (Stage I-IV), Diabetic ulcers , Surgical wounds (e.g. post-operative, donor sites, dermatological) ,Pressure ulcers, Burns (1st and 2nd degree), and Surgical or traumatic wounds which have been left to heal by secondary intention. SURECELL Gelling Fiber Wound Dressing maintains a moist wound environment. SURECELL Gelling Fiber Wound Dressing may also be used for the local management of wounds such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds. SURECELL Gelling Fiber Wound Dressing Over-the-Counter is indicated for minor Burns, minor abrasions and minor Lacerations, minor superficial cuts. SURECELL Gelling Fiber Wound Dressing is intended for the maintenance of a moist wound environment.

Source page: https://510kreport.com/device/K173005
Methodology: https://510kreport.com/methodology