# K983362: NU-Gel * Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Dec 16, 1998 after 83 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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.
107 later devices descend from it; 3 cite it directly.
0 of 109 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.

## Most influential descendants
- K022995: Collatek Hydrogel (2002), 106 descendants of its own
- K040019: Silverseal (2004), 97 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own

## Indications for use
NU-GEL” Wound Dressing is a sterile hydrogel formulation of preserved polyvinyl pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL" Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination and absorbs exudate from the wound. NU-GEL Wound Dressing is indicated for dry, light and moderately exuding partial and full thickness wounds such as: First and second degree bumns Severe sunbums Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears NU-GEL*" Wound Dressing should be used under health care professional direction for the following indications: Bums caused by radiation oncology procedures Pressure ulcers Stage -V Lower extremity ulcers Venous ulcers Anerial ulcers Ulcers of mixed etiology Diabetic ulcers Donor sites and skin grafts Precautions: NU-GEL* Wound Dressing is not indicated for use on the following: Third degree bumns Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional. NU-GEL* Wound Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. NU-GEL" Wound Dressing may be used under compression therapy with healthcare profession supervision..

Source page: https://510kreport.com/device/K983362
Methodology: https://510kreport.com/methodology