510(k) Report

FDA applicant

Surgical Navigation Technologies, Inc.

Broomfield, CO27 decisions1996–200045 recalls

FDA records 27 decisions for Surgical Navigation Technologies, Inc. (Broomfield, CO) from 1996 to 2000: 27 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and IYE (Accelerator, Linear, Medical). Its devices cite 12 predicates, 7 of them its own earlier devices. 45 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Surgical Navigation Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgical Navigation Technologies, Inc. since 2007.

Recalls per year

1in 2026

2008: 12010: 12011: 22012: 32013: 12014: 252015: 32016: 12019: 32026 (partial year): 1
2007high 25 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgical Navigation Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Navigation Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument15decisions
  • IYEAccelerator, Linear, Medical7decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • HRXArthroscope1decision
  • LMDSystem, Digital Image Communications, Radiological1decision

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 62 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K954276StealthstationSurgical Navigation Technologies, Inc. · 199623cite it
  • K990214Fluoronav Module for the Stealthstation SystemSurgical Navigation Technologies, Inc. · 19996cite it
  • K972398Stealthstation Passive Instrument OptionSurgical Navigation Technologies, Inc. · 19974cite it
  • K971247SNT Disposable Biopsy NeedleSurgical Navigation Technologies, Inc. · 19973cite it
  • K992927Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 19993cite it
  • K994355Radiocameras System Head/Neck ApplicationSurgical Navigation Technologies, Inc. · 20002cite it

What has FDA decided for it lately?

  • K000246Radiocameras Extracranial SystemSurgical Navigation Technologies, Inc. · 2000
  • K994355Radiocameras System Head/Neck ApplicationSurgical Navigation Technologies, Inc. · 2000
  • K992461Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 2000
  • K992927Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 19992 recalls
  • K993021Metrx SystemSurgical Navigation Technologies, Inc. · 19993 recalls
  • K992354SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999
  • K991468Immerge Image CorrelationSurgical Navigation Technologies, Inc. · 1999
  • K990214Fluoronav Module for the Stealthstation SystemSurgical Navigation Technologies, Inc. · 199929 recalls

All 27 as Surgical Navigation Technologies, Inc. →

What has been recalled?

45 recalls linked to its devices; the latest:

  • K971247Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, RxonlyAug 31, 2026Class II
  • K971247Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943Oct 30, 2019Class II
  • K971247Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517Oct 30, 2019Class II
  • K971247Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108Oct 30, 2019Class II
  • K992927S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in…Jul 18, 2016Class II
  • K971247Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use…Jul 17, 2015Class II