# K971089: Opportunity, Inc. Laceration Tray

- Pathway: 510(k) (Traditional)
- Applicant: Opportunity, Inc.
- Decided: Sep 16, 1997 after 176 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 no predicate by number.

## Indications for use
Opportunity Inc.’s Laceration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change ( from the manufacturers original intended use. This kit is used for performing or assisting in performing laceration procedures.

Source page: https://510kreport.com/device/K971089
Methodology: https://510kreport.com/methodology