# K123193: Ipm Wound Gel Bio

- Pathway: 510(k) (Traditional)
- Applicant: Glycobiosciences, Inc.
- Decided: Mar 3, 2014 after 508 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: 3 generations back to K830708 (1983). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984413: Bionect Hydrogel, Fidia Pharmaceutical Corp. (1999) Summary page 1.
- K020325: L.a.M. Ipm Wound Gel, L.A.M. Pharmaceutical, Corp. (2002) Summary page 1.

## Most influential descendants
- K143527: IPM Wound Gel Bio, IPM Derm Gel Bio (2015), 0 descendants of its own

## Indications for use
1PM Wound 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. Rx: Under the supervision of a health care professional: - IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.

Source page: https://510kreport.com/device/K123193
Methodology: https://510kreport.com/methodology