# K082208: Doctors Choice Slow Healing Bandage with Spray on Remover

- Pathway: 510(k) (Traditional)
- Applicant: Scivolutions, Inc.
- Decided: Dec 1, 2008 after 118 days
- Product code: NAC (Dressing, Wound, Hydrophilic)
- Device class: 1
- Regulation: 21 CFR 878.4018
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K992817 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032983: Sensitive Skin Antibacterial Bandages, Scivolution, Inc. (2004) Summary page 2.
- K974348: Algoplaque Film Extra Thin Hydrocolloid Dressing, Laboratoires Urgo S.A. (1998) Summary page 2.
- K982892: 3M Tegasorb Thin Hydrocolloid Dressing, 3M Company (1998) Summary page 2.
- K973716: Duoderm Extra Thin CGF Dressing, Convatec, A Bristol-Myers Squibb Co. (1997) Summary page 2.

## Indications for use
The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.

Source page: https://510kreport.com/device/K082208
Methodology: https://510kreport.com/methodology