Clarus Endoscopic Neurological Tissue Elevator
FDA 510(k) K942413 · Clarus Medical Systems, Inc.
510(k) numberK942413
Submission
- Device name
- Clarus Endoscopic Neurological Tissue Elevator
- Applicant
- Clarus Medical Systems, Inc.
Minneapolis, MN, US - Received
- May 20, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | 08/18/1998SE |
| K974579 | Percscope Model 2600HRX · Traditional | 02/18/1998SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | 05/23/1997SE |
| K971455 | Clarus Model 5197 SightliteFTI · Traditional | 05/20/1997SE |
| K960915 | Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional | 12/24/1996SE |
| K962255 | Clarus Murphypen ENDOSCOPE(2127-XXX)EOB · Traditional | 09/11/1996SE |
| K955598 | Clarus Spinepen Model 2126GWG · Traditional | 02/06/1996SE |
| K953685 | Instrument ScopeGWG · Traditional | 10/12/1995SE |
| K945633 | Neuro Channel Endoscope Model 2232GWG · Traditional | 09/19/1995SE |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional | 07/14/1995SE |
Questions and answers
When was Clarus Endoscopic Neurological Tissue Elevator cleared by the FDA?
Clarus Endoscopic Neurological Tissue Elevator (K942413) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 186 days after the submission was received.
What is the product code of K942413?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.