# K102460: Ambit Introducer, Ambit Needle, Ambit Sheath

- Pathway: 510(k) (Abbreviated)
- Applicant: Summit Medical Products, Inc.
- Decided: Jan 13, 2011 after 139 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K200624: Percutaneous Introducer (2020), 0 descendants of its own
- K171584: B. Braun Tear-Away Introducer Needle (2017), 0 descendants of its own

## Indications for use
The ambiT Introducer product line is intended to allow the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle The ambiT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.

Source page: https://510kreport.com/device/K102460
Methodology: https://510kreport.com/methodology