# K023173: Andrews Introducer, Model ASI01

- Pathway: 510(k) (Traditional)
- Applicant: Andrews Surgical Innovations, Ltd.
- Decided: Dec 18, 2002 after 86 days
- Product code: MDM (Instrument, Manual, Surgical, General Use)
- 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
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 its predicate without a number.
- (no number) Roberts' Forceps: named in the summary without a submission number
- (no number) Tube Introduction Forceps: named in the summary without a submission number

## Indications for use
The Andrews IntroducerTM is specifically designed for the insertion of intercostal chest tubes.

Source page: https://510kreport.com/device/K023173
Methodology: https://510kreport.com/methodology