# K980097: Flexigel-G Hydrogel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: Mar 4, 1998 after 51 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K920097: MRT-50 QD Head Coil, Toshiba America Mri, Inc. (1992). Our OCR of the scanned summary read K920097, FDA’s number for MRT-50 QD Head Coil (Toshiba America Mri, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intrasite™ Gel”. Kept off the family tree. Summary page 1.

## Indications for use
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.: Pressure Ulcers Venous Stasis Ulcers Diabetic Ulcers 1st and 2nd Degree Burns Surgical Wounds Trauma Wounds Dermal Lesions (Cuts, abrasions, etc) FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as: Superficial cuts Abrasions Lacerations Minor scalds Minor burns Minor skin irritations

Source page: https://510kreport.com/device/K980097
Methodology: https://510kreport.com/methodology