# K970660: Dermagran Wound Management System

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Aug 12, 1997 after 172 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944491 (1994). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 1.
- K954743: Dermagran Wound Dressing Cleaner W/Zinc, Derma Sciences, Inc. (1995) Summary page 1.
- K944491: Dermagran Hydrophilic Ointment, Derma Sciences, Inc. (1994) Summary page 1.
- K954739: Dermagran Hydrophilic Ointment, Derma Sciences, Inc. (1995) Summary page 1.
- K963603: Dermagran Hydrophilic Ointment, Derma Sciences, Inc. (1996) Summary page 1.

## Most influential descendants
- K080779: Irrisept Wound Cleansing System (2009), 9 descendants of its own
- K202222: Irrisept Wound Debridement and Cleansing System (2020), 7 descendants of its own
- K210536: Irrisept Antimicrobial Wound Lavage (2021), 6 descendants of its own
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 descendants of its own
- K213616: BD Surgiphor Antimicrobial Irrigation System (2022), 3 descendants of its own

## Indications for use
Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System s conducive to wound healing and autolytic debridement. The System is useful in the management of various skin injuries which result in lacerations, abrasions. post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.

Source page: https://510kreport.com/device/K970660
Methodology: https://510kreport.com/methodology