# K971247: SNT Disposable Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Jun 16, 1997 after 74 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Stereotactic biopsy needle manufactured by RADIONICS and used in their Nashold Biopsy Needle Kit: named in the summary without a submission number

## Most influential descendants
- K143241: MDT Navigable Brain Biopsy Cannula (2015), 2 descendants of its own
- K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (2023), 1 descendant of its own
- K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (2024), 0 descendants of its own
- K140705: Navigable Brain Biopsy Cannula Set (2014), 0 descendants of its own
- K990632: Optical Tracking System (Ots) (1999), 0 descendants of its own

## Recalls of this device
- Aug 31, 2026 · Class II · Z-0197-2027: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
- Oct 30, 2019 · Class II · Z-0657-2020: The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tigh
- Oct 30, 2019 · Class II · Z-0658-2020: The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tigh
- Oct 30, 2019 · Class II · Z-0659-2020: The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tigh
- Jul 17, 2015 · Class II · Z-2325-2015: The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper 
- Jul 17, 2015 · Class II · Z-2324-2015: The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper 

## Indications for use
The SNT DISPOSABLE BIOPSY NEEDLE js intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it’s rigid needle guide holder. The biopsy needle is supplied sterile and is intended for single use only.

Source page: https://510kreport.com/device/K971247
Methodology: https://510kreport.com/methodology