# K040517: Tenderwet Active

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 25, 2004 after 27 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TenderWet® active and TenderWet® active Cavity are for the wet maaagement of dry, Ilight and moderately exudating partial and full thickness wounds such as mrinor burns, superficia! injuries, lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears. TeaderWet active m y also be used under the direction of a health care professional for chronic wounds such as pressure ulers, lower extr:emity ulcers, venous ulcers, arterial ulcers, 'diabetic ulcers, and ulcers of mixed etiology.

Source page: https://510kreport.com/device/K040517
Methodology: https://510kreport.com/methodology