# K171239: TULA Tube Delivery System

- Pathway: 510(k) (Special)
- Applicant: Tusker Medical
- Decided: Jun 28, 2017 after 62 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830228 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103595: Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System, Acclarent, Inc. (2011) Summary page 4.

## Indications for use
The Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.

Source page: https://510kreport.com/device/K171239
Methodology: https://510kreport.com/methodology