# K041704: Newgel and Newgel Plus E

- Pathway: 510(k) (Traditional)
- Applicant: Newmedical Technology, Inc.
- Decided: Oct 17, 2005 after 481 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- 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) Cica-Care adhesive gel sheeting: named in the summary without a submission number
- (no number) TopiGel silicone gel sheeting: named in the summary without a submission number

## Indications for use
For the management of hypertrophic and keloid scars

Source page: https://510kreport.com/device/K041704
Methodology: https://510kreport.com/methodology