# K984388: HA Absorbent Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Mar 3, 1999 after 85 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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.
90 later devices descend from it; 2 cite it directly.
1 of 91 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FIBRACOL Collagen-Alginate Wound Dressing: named in the summary without a submission number
- (no number) Knitted Wound Dressing (Ribbon): named in the summary without a submission number

## Most influential descendants
- K020325: L.a.M. Ipm Wound Gel (2002), 59 descendants of its own
- K090725: Oculus Microcyn Wound Gel (2009), 56 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own

## Indications for use
For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional, HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds. HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.

Source page: https://510kreport.com/device/K984388
Methodology: https://510kreport.com/methodology