Digital ClarusScope System, Digital NeuroPEN System
FDA 510(k) K223615 · Clarus Medical, LLC
510(k) numberK223615
Submission
- Device name
- Digital ClarusScope System, Digital NeuroPEN System
- Applicant
- Clarus Medical, LLC
Plymouth, MN, US - Received
- December 5, 2022
- Decision date
- November 21, 2023
- 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 Stryker
| 510(k) | Device | Decision |
|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | 05/26/2026SE |
| K240535 | Digital ClarusScope System; Digital NeuroPEN SystemHRX · Traditional | 04/25/2024SE |
| K200925 | Clarus Peel-Away Introducer SheathGWG · Traditional | 03/18/2021SE |
| K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-VBTR · Traditional | 04/28/2009SE |
| K040919 | Nucleotome Probe Set, Model 21200HRX · Traditional | 06/01/2004SE |
| K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…GEX · Traditional | 05/11/2004SE |
| K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160GEX · Traditional | 11/05/2002SE |
| K021848 | Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160GEX · Traditional | 09/03/2002SE |
| K011454 | Spine Scope, Model 2180HRX · Traditional | 12/13/2001SE |
Questions and answers
When was Digital ClarusScope System, Digital NeuroPEN System cleared by the FDA?
Digital ClarusScope System, Digital NeuroPEN System (K223615) received a 510(k) decision of Substantially Equivalent on November 21, 2023, 351 days after the submission was received.
What is the product code of K223615?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.