# K043425: Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and Cover)

- Pathway: 510(k) (Traditional)
- Applicant: Sheathing Technologies, Inc.
- Decided: Feb 28, 2005 after 77 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K882383 (1988). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931403: Siterite Needle Guide (Modified), Dymax Corp (1993) Summary page 1.
- K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides, CIVCO Medical Instruments Co., Inc. (1988)

## Most influential descendants
- K083667: Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337 (2009), 3 descendants of its own
- K160806: Verza Guidance System (2016), 2 descendants of its own
- K262474: ND Needle Guidance System (2026), 0 descendants of its own
- K250524: Mendaera Guidance System (2025), 0 descendants of its own

## Indications for use
The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound transducer and the resulting image during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.

Source page: https://510kreport.com/device/K043425
Methodology: https://510kreport.com/methodology