# K110814: Ambit Tunneler

- Pathway: 510(k) (Abbreviated)
- Applicant: Summit Medical Products, Inc.
- Decided: Apr 8, 2011 after 15 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- 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 K063234 (2006). 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)
- K063234: ON-Q Introducers, I-Flow Corp. (2006) Summary page 1.

## Indications for use
The anibiT Tunntelers are intended for the percuitaneous introduction of catheters.

Source page: https://510kreport.com/device/K110814
Methodology: https://510kreport.com/methodology