# K963894: Smartguide

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Mar 11, 1997 after 165 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Homer MammalLock Ultra Repositionable Breast Localization Needle: named in the summary without a submission number
- (no number) Goose-Neck Snare: named in the summary without a submission number
- (no number) Wittich Nitinol Stone Basket: named in the summary without a submission number

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
The SmartGuide is intended for use in punctures of anatomical sites such as organs, cysts, lymph nodes, and tissue spaces, for purposes of aspiration biopsy, drainage, injection, or fluid collection. SmartGuide can be used in punctures where non-penetrable anatomic obstacles (e.g. bone, spine) or vital structures (e.g. blood vessels, nerves) are to be avoided. The device is intended for use in radiographic environments such as CT and ultrasound.

Source page: https://510kreport.com/device/K963894
Methodology: https://510kreport.com/methodology