# K991202: Modification to Woun'dres

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Jun 4, 1999 after 74 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 K894541 (1989). 2 ancestors in all.
112 later devices descend from it; 6 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894541: Carrington Dermal Wound Gel, Carrington Laboratories, Inc. (1989) Summary page 1.
- K925993: Duoderm Hydroactive Dressing, Convatec, A Division of E.R. Squibb & Sons (1993) 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
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.

Source page: https://510kreport.com/device/K991202
Methodology: https://510kreport.com/methodology