# K993376: Enstylet Models EC0010, EC0020

- Pathway: 510(k) (Traditional)
- Applicant: Endocardial Solutions, Inc.
- Decided: Jan 5, 2000 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Intermedics Stylets Models 365-81, 365-82, 365-89, 365-90: named in the summary without a submission number
- (no number) Pacesetter Locator Steerable Stylet Model 4036: named in the summary without a submission number

## Indications for use
The EnStylet™ EC0010/20 is intended for use in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System. The EnStylet™ is designed to provide deflection and positioning of the distal end of the catheter.

Source page: https://510kreport.com/device/K993376
Methodology: https://510kreport.com/methodology