Clarus Phoenix Neuro Endoscope Model 2160
FDA 510(k) K945296 · Clarus Medical Systems, Inc.
510(k) numberK945296
Submission
- Device name
- Clarus Phoenix Neuro Endoscope Model 2160
- Applicant
- Clarus Medical Systems, Inc.
Minneapolis, MN, US - Received
- October 31, 1994
- Decision date
- July 14, 1995
- 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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| 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 |
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| K941188 | Clarus Neuro Endoscope (Model 2230)HRX · Traditional | 04/25/1995SE |
Questions and answers
When was Clarus Phoenix Neuro Endoscope Model 2160 cleared by the FDA?
Clarus Phoenix Neuro Endoscope Model 2160 (K945296) received a 510(k) decision of Substantially Equivalent on July 14, 1995, 256 days after the submission was received.
What is the product code of K945296?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.