# K973260: Hydrasorb Sterile Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Avitar, Inc.
- Decided: Oct 21, 1997 after 53 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Lyofoam Sterile Dressings: named in the summary without a submission number
- (no number) Epi-Lock Wound Dressings: named in the summary without a submission number
- (no number) Allevyn Hydrophilic Polyurethane Foam: named in the summary without a submission number
- (no number) Hydrasorb Sterile Dressings distributed by Calgon Vestal: named in the summary without a submission number

## Most influential descendants
- K070457: Sun Scientific LLC-Leg Compressor and Pfab (2007), 0 descendants of its own

## Indications for use
Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moist healing environment, manage exudate, and protect the wound from contamination. Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds. Hydrasorb Sterile Dressing -Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment. It is an ideal dressing in the local management of exudate that may occur at surgically induced body drainage sites such as a tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump drain. In general it can be used anywhere there is a need to manage the surrounding skin due to potential skin irritation or maceration.

Source page: https://510kreport.com/device/K973260
Methodology: https://510kreport.com/methodology