# K961662: Advanced Care Hydrophilic Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Mariner Biomedical, Inc.
- Decided: Jun 13, 1996 after 44 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- 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. The FDA summary names its predicate without a number.
- (no number) Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing: named in the summary without a submission number

## Indications for use
The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, lacerations, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.

Source page: https://510kreport.com/device/K961662
Methodology: https://510kreport.com/methodology