# K982638: 3M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: Aug 21, 1998 after 23 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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 K953781 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953781: Innovative Technologies Calcium Alginate Wound Dressings, Innovative Technologies, Ltd. (1995) Summary page 6.
- K980989: 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing, Innovative Technologies, Ltd. (1998) Summary page 6.

## Indications for use
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds o Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

Source page: https://510kreport.com/device/K982638
Methodology: https://510kreport.com/methodology