# K960520: Laceration Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medco Instruments, Inc.
- Decided: Mar 21, 1996 after 44 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920341 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920341: Laceration Trays, Medikmark, Inc. (1992) Summary page 1.

## Indications for use
The Laceration Tray is an assemblage of surgical accessories, each of which is intended to be used in accordance with generally accepted minor surgical procedures.

Source page: https://510kreport.com/device/K960520
Methodology: https://510kreport.com/methodology