# K023630: Essex Aspiration/Irrigation Instrument with Positioning Guide, Model SY-1400

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation, Cardiac Surgery
- Decided: Feb 20, 2003 after 115 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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) Karl Storz Suction/Irrigation Instrument: named in the summary without a submission number

## Indications for use
The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.

Source page: https://510kreport.com/device/K023630
Methodology: https://510kreport.com/methodology