# K980962: Brennen Medical Beta Glucan Cream, Macropro

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, Inc.
- Decided: Jul 29, 1998 after 135 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
MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin. MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough. For external use only. Do not use on patients with known allergies to plants such as gum oat.

Source page: https://510kreport.com/device/K980962
Methodology: https://510kreport.com/methodology