# K083667: Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Feb 2, 2009 after 53 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: 2 generations back to K882383 (1988). 3 ancestors in all.
3 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)
- K043425: Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and Cover), Sheathing Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
Needle guide(s): provides guidance for-needles or other :interventidnal:devices during an ultrasound-guideda'proced'ure. It positions the needle relative to the:transducer, so that the needle image is :ina specified position in the ultrasound image during procedcures. that require precise needle placement or biopsy.

Source page: https://510kreport.com/device/K083667
Methodology: https://510kreport.com/methodology