# K032242: Personna Plus Safety Scalpel System

- Pathway: 510(k) (Traditional)
- Applicant: Omi Manufacturing Pty., Ltd.
- Decided: Sep 23, 2003 after 64 days
- Product code: GES (Blade, Scalpel)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K924503 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923170: Los Alamos Retractable Knife, Innovative Surgical Technology, Inc. (1993) Summary page 1.
- K924503: Personna Safety Scalpel, American Safety Razor Co. (1993) Summary page 1.

## Indications for use
The PersonnaPIus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading. passing, and disposal.

Source page: https://510kreport.com/device/K032242
Methodology: https://510kreport.com/methodology