# K062795: Mugard Mucoadhesive Oral Wound Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Access Pharmaceuticals, Inc.
- Decided: Dec 11, 2006 after 84 days
- Product code: OLR (Oral Wound Dressing)
- 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: 2 generations back to K964852 (1997). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024180: Oramagicrx Oral Wound Rinse, Mpm Medical., Inc. (2003) Summary page 1.
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001)

## Most influential descendants
- K140558: Proctigard (2014), 4 descendants of its own
- K213552: PuraStat-RM (2022), 3 descendants of its own
- K242634: PuraStat (2025), 2 descendants of its own
- K253923: PuraStat (2026), 1 descendant of its own
- K261504: PuraStat-RM (2026), 0 descendants of its own

## Indications for use
MuGardTM Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

Source page: https://510kreport.com/device/K062795
Methodology: https://510kreport.com/methodology