# K082322: Air Assisted Sprayer, Models: AIRSPRAYUS01 and Airsprayus

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Nov 14, 2008 after 93 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
Longest line of descent: 1 generation back to K042834 (2005). 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)
- K042834: Micromedics Fibrijet Air Assisted Endoscopic Applicator, Micromedics, Inc. (2005) Summary page 1.

## Indications for use
The Air Assisted Sprayer is intended to deliver two non-homogenous solutions onto a surgical site.

Source page: https://510kreport.com/device/K082322
Methodology: https://510kreport.com/methodology