# K243415: Granudacyn® Wound Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: P.G.F. Industry Solutions GmbH
- Decided: Jul 22, 2025 after 263 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 10 generations back to K914579 (1992). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ), Puricore, Inc. (2014) Summary page 5.

## Most influential descendants
- K261023: Microdacyn Wound Irrigation Solution (2026), 0 descendants of its own

## Indications for use
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K243415
Methodology: https://510kreport.com/methodology