# K051860: Flexible Introducer Cannula, Model 135-1837

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Aug 22, 2005 after 45 days
- Product code: MIA (Needle, Spinal, Short Term)
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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 K904380 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904380: Spinal Cord Access Epidural Introducer System, Custom Medical Concepts, Inc. (1993) Summary page 1.

## Most influential descendants
- K200624: Percutaneous Introducer (2020), 0 descendants of its own

## Indications for use
The Flexible Introducer Cannula is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.

Source page: https://510kreport.com/device/K051860
Methodology: https://510kreport.com/methodology