# K200624: Percutaneous Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Apr 27, 2020 after 48 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: 2 generations back to K904380 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102460: Ambit Introducer, Ambit Needle, Ambit Sheath, Summit Medical Products, Inc. (2011) Summary page 4.
- K051860: Flexible Introducer Cannula, Model 135-1837, Epimed International, Inc. (2005) Summary page 4.

## Indications for use
The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, such as catheters, needles or probes, 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/introducer.

Source page: https://510kreport.com/device/K200624
Methodology: https://510kreport.com/methodology