# K962851: Acrynoodles Absorbent Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acrymed, Inc.
- Decided: Sep 6, 1996 after 46 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 FDA summary names its predicate without a number.
- (no number) AcryDerm Advanced Wound Dressing: named in the summary without a submission number
- (no number) Kaltostat Wound Dressing: named in the summary without a submission number
- (no number) Aquaflo Hydrogel Wound Dressing/Packer: named in the summary without a submission number

## Indications for use
AcryNoodles is intended as an external wound dressing for use in the management of exudate from chronic wounds such as pressure sores, arterial ulcers, diabetic ulcers, and venous stasis ulcers and acute wounds such as draining surgical wounds, lacerations, donor site, and exudating first and second degree burns, and abrasions. It is not intended for use on third degree burns.

Source page: https://510kreport.com/device/K962851
Methodology: https://510kreport.com/methodology