# K143527: IPM Wound Gel Bio, IPM Derm Gel Bio

- Pathway: 510(k) (Traditional)
- Applicant: Glycobiosciences, Inc.
- Decided: Apr 20, 2015 after 129 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: 7 generations back to K830708 (1983). 21 ancestors in all.
No later device cites it as a predicate yet.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123193: Ipm Wound Gel Bio, Glycobiosciences, Inc. (2014) Summary page 5.
- K130781: L.a.M. Ipm Wound Gel, Ipm Derm Gel, Glycobiosciences, Inc. (2014) Summary page 5.

## Indications for use
IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions. Under the supervision of a healthcare professional: • IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically or surgically debrided wounds, and for second degree burns. • IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis.

Source page: https://510kreport.com/device/K143527
Methodology: https://510kreport.com/methodology