Neuroview Coaxial Bipolar Electrode
FDA 510(k) K955351 · Neuro Navigational Corp.
510(k) numberK955351
Submission
- Device name
- Neuroview Coaxial Bipolar Electrode
- Applicant
- Neuro Navigational Corp.
Costa Mesa, CA, US - Received
- November 21, 1995
- Decision date
- February 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Hjy Smart Medical Device Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K965078 | 2.1MM Semi-Rigid Neuroview SCISSORS/2.0OMM Semi-Rigid Neuroview Grasping ForcepsGWG · Traditional | 03/06/1997SE |
| K961406 | Neuroview ScissorsGWG · Traditional | 06/13/1996SE |
| K961300 | Aspiration/Irrigation CatheterGWG · Traditional | 06/07/1996SE |
| K961173 | 1.2MM Reusable Neuroview EndoscopeGWG · Traditional | 06/07/1996SE |
| K960792 | Disposable Neuroview Introducer SheathGWG · Traditional | 04/11/1996SE |
| K954938 | Disposable Neuroview Operating SheathGWG · Traditional | 03/07/1996SE |
| K954899 | Rigid Neuroview EndoscopeGWG · Traditional | 12/19/1995SE |
| K955467 | Neuroview Coaxial Bipolar ElectrodeGEI · Traditional | 12/18/1995SE |
| K955037 | Rigid Neuroview EndoscopeHRX · Traditional | 12/04/1995SN |
| K952639 | Disposable Toothed Grasping ForcepHRX · Traditional | 09/08/1995SE |
Questions and answers
When was Neuroview Coaxial Bipolar Electrode cleared by the FDA?
Neuroview Coaxial Bipolar Electrode (K955351) received a 510(k) decision of Substantially Equivalent on February 29, 1996, 100 days after the submission was received.
What is the product code of K955351?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.