# K042287: Uniplain & Unichrom

- Pathway: 510(k) (Traditional)
- Applicant: United Medical Industries Co., Ltd.
- Decided: Sep 7, 2005 after 379 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- 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
UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.

Source page: https://510kreport.com/device/K042287
Methodology: https://510kreport.com/methodology