# K060182: Trumpet Valve Handle with 3-Metre Tubing, Single Spike, 5MM Cannula, Trumpet Valve Handle with 3-Metre Tubing, Double

- Pathway: 510(k) (Traditional)
- Applicant: Australian Surgical Devices
- Decided: Sep 7, 2006 after 226 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 K003443 (2001). 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)
- K003443: Suction Irrigator, Applied Medical (2001) Summary page 1.

## Indications for use
The ASD-TactileTM Suction and Irrigation System is a sterile, single-use device indicated for use in patients undergoing general laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K060182
Methodology: https://510kreport.com/methodology