Navigable Brain Biopsy Cannula Set
FDA 510(k) K140705 · Izi Medical Products
510(k) numberK140705
Submission
- Device name
- Navigable Brain Biopsy Cannula Set
- Applicant
- Izi Medical Products
Owings Mills, MD, US - Received
- March 21, 2014
- Decision date
- December 5, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K191012 | Navigated Pedicle Access KitOLO · Traditional | 08/07/2019SE |
| K162265 | CushionCast Moldable CushionsIYE · Traditional | 11/15/2016SE |
| K143241 | MDT Navigable Brain Biopsy CannulaHAW · Traditional | 04/13/2015SE |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation SystemHAW · Traditional | 03/20/2015SE |
| K101373 | EmbraceIZH · Traditional | 09/15/2010SE |
Questions and answers
When was Navigable Brain Biopsy Cannula Set cleared by the FDA?
Navigable Brain Biopsy Cannula Set (K140705) received a 510(k) decision of Substantially Equivalent on December 5, 2014, 259 days after the submission was received.
What is the product code of K140705?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.