# K040001: Steerable Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Surgical Innovations
- Decided: Mar 9, 2004 after 67 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- 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 K972814 (1998). 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)
- K972814: Locator Model 4036, Pacesetter, Inc. (1998) Summary page 1.

## Indications for use
The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

Source page: https://510kreport.com/device/K040001
Methodology: https://510kreport.com/methodology