# K982439: Proxiderm, Models TN 460, TN 90 460, BK 460

- Pathway: 510(k) (Traditional)
- Applicant: Progressive Surgical Products, Inc.
- Decided: Sep 8, 1998 after 56 days
- Product code: MKY (System, Skin Closure)
- Device class: 1
- Regulation: 21 CFR 878.4320
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Proxiderm is intended to be utilized prior to a surgical procedure to remove a defect or prior to implantation of a prosthesis to provide additional skin for coverage of the defect or prosthesis.

Source page: https://510kreport.com/device/K982439
Methodology: https://510kreport.com/methodology