# K972062: Convatec Non-Adhesive Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Aug 14, 1997 after 72 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
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) ConvaTec’s CombiDERM™ ACD™: named in the summary without a submission number

## Indications for use
ConvaTec Non-Adhesive Dressing is indicated for use on moderately to heavily exuding chronic wounds such as pressure ulcers, leg ulcers and diabetic ulcers, and on moderately to heavily exuding acute wounds such as abrasions, lacerations, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.

Source page: https://510kreport.com/device/K972062
Methodology: https://510kreport.com/methodology