510(k) · Cleared
Recalled · Class II · 2026SNT Disposable Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Navigation Technologies, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 16, 1997 after a 74-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 16, 1997
- Review
- 74 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 6
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK971247 SNT Disposable Biopsy NeedleSurgical Navigation Technologies, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK143241 MDT Navigable Brain Biopsy CannulaIzi Medical Products, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK212194 Stryker Q Guidance System with Cranial Guidance Software…Stryker Corporation · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · cites it directly · 0 of its ownK140705 Navigable Brain Biopsy Cannula SetIzi Medical Products · 2014
- Descendant · cites it directly · 0 of its ownK990632 Optical Tracking System (Ots)Radionics, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K143241MDT Navigable Brain Biopsy CannulaIzi Medical Products, LLC · 2015 · cites it directly2descendants
- K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation · 2023 · 2 generations on1descendant
- K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG · 2024 · 3 generations on0descendants
- K140705Navigable Brain Biopsy Cannula SetIzi Medical Products · 2014 · cites it directly0descendants
- K990632Optical Tracking System (Ots)Radionics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971247 | SNT Disposable Biopsy Needle | Surgical Navigation Technologies, Inc. | 1997 | — |
| +1 | K143241 | MDT Navigable Brain Biopsy Cannula | Izi Medical Products, LLC | 2015 | — |
| +2 | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker… | Stryker Corporation | 2023 | 2 |
| +3 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +1 | K140705 | Navigable Brain Biopsy Cannula Set | Izi Medical Products | 2014 | — |
| +1 | K990632 | Optical Tracking System (Ots) | Radionics, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Stereotactic biopsy needle manufactured by RADIONICS and used in their Nashold Biopsy… Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2026 | Class II | Z-0197-2027 | Under Investigation by firm | 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 | Process control | 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 tighten to the biopsy needle. This could… |
| Oct 30, 2019 | Class II | Z-0658-2020 | Process control | 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 tighten to the biopsy needle. This could… |
| Oct 30, 2019 | Class II | Z-0659-2020 | Process control | 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 tighten to the biopsy needle. This could… |
| Jul 17, 2015 | Class II | Z-2325-2015 | Process change control | 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 placement of the needles biopsy window… |
| Jul 17, 2015 | Class II | Z-2324-2015 | Process change control | 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 placement of the needles biopsy window… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143241 (Izi Medical Products, LLC, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971247: SNT Disposable Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971247
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026