# K121776: Agility Steerable Guidewire Neuroscout Steerable Gudiewire

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Aug 14, 2012 after 57 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K991646 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991646: Agility Steerable Guidewire, Cordis Neurovascular, Inc. (1999) Summary page 1.
- K001033: Agility Steerable Guidewire, Cordis Neurovascular, Inc. (2000) Summary page 1.
- K010511: Modification to: Agility Steerable Guidewires, Cordis Neurovascular, Inc. (2001) Summary page 1.
- K100351: Neuroscout Steerable Guidewire, Codman & Shurtleff, Inc. (2010) Summary page 1.

## Most influential descendants
- K133625: Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM & XL 350CM, Agility 16 Standard & (2014), 0 descendants of its own

## Indications for use
The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature. The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K121776
Methodology: https://510kreport.com/methodology