Navigus Passive Probe (BL), Model NP-2000
FDA 510(k) K040834 · Image-Guided Neurologics, Inc.
510(k) numberK040834
Submission
- Device name
- Navigus Passive Probe (BL), Model NP-2000
- Applicant
- Image-Guided Neurologics, Inc.
Melbourne, FL, US - Received
- March 31, 2004
- Decision date
- June 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K050772 | Navigus Reusable Passive Probe, Model SP-2000HAW · Traditional | 04/21/2005SE |
| K043091 | Navigus Nexdrive, Model MI-3000HAW · Traditional | 02/07/2005SE |
| K040334 | Navigus Passive Probe, Model NP-1000HAW · Traditional | 10/04/2004SE |
| K033619 | Navigus Unibody Fiducial Marker System, Model FM-4000HAW · Traditional | 03/02/2004SE |
| K031885 | Navigus Passive Head Restraint System, Model Hr-XxxHBL · Traditional | 08/21/2003SE |
| K024201 | Navigus Fiducial Marker System, Models FM-1000, FM-2000HAW · Traditional | 03/12/2003SE |
| K023949 | Navigus II Trajectory Guide with Verification ReticulesHAW · Traditional | 02/25/2003SE |
| K022100 | Navigus Manual Disposable Microdrive with Digital Display, Models MI-1000 & MI-1010HAW · Traditional | 09/25/2002SE |
| K012719 | Navigus II MRHAW · Traditional | 10/22/2001SE |
| K012366 | Navigus II Trajectory GuideHAW · Traditional | 10/01/2001SE |
Questions and answers
When was Navigus Passive Probe (BL), Model NP-2000 cleared by the FDA?
Navigus Passive Probe (BL), Model NP-2000 (K040834) received a 510(k) decision of Substantially Equivalent on June 3, 2004, 64 days after the submission was received.
What is the product code of K040834?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.