Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
FDA 510(k) K201840 · Rebound Therapeutics
510(k) numberK201840
Submission
- Device name
- Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
- Applicant
- Rebound Therapeutics
Irvine, CA, US - Received
- July 2, 2020
- Decision date
- November 4, 2020
- 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).
Other 510(k)s with product code GWG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253602 | Precision S 4K SinuscopeGWG · Traditional | Stryker Endoscopy | 06/04/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | Stryker Instruments | 05/08/2026SE |
| K243429 | HJY VisualNext 3D Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 05/21/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | Integra LifeSciences Corporation | 04/09/2025SE |
| K233391 | cCeLL - In vivoGWG · Traditional | VPIX Medical, Inc. | 08/21/2024SE |
| K223615 | Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional | Clarus Medical, LLC | 11/21/2023SE |
| K232618 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 10/27/2023SE |
| K230125 | Neuroblade SystemGWG · Traditional | Clearmind Biomedical | 10/13/2023SE |
| K232159 | QEVO SystemGWG · Special | Carl Zeiss Meditec, AG | 09/21/2023SE |
| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
More from Hjy Smart Medical Device Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232618 | Aurora Surgiscope SystemGWG · Traditional | 10/27/2023SE |
| K203745 | AURORA Evacuator +CoagGEI · Traditional | 12/02/2021SE |
| K201637 | Aurora Evacuator +CoagGEI · Traditional | 08/12/2020SE |
| K191861 | Aurora Surgiscope SystemGWG · Traditional | 12/06/2019SE |
| K190075 | Aurora EvacuatorGEI · Special | 02/12/2019SE |
| K182211 | Aurora Surgiscope SystemGWG · Traditional | 01/18/2019SE |
| K180372 | Aurora EvacuatorGEI · Traditional | 04/09/2018SE |
Questions and answers
When was Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) cleared by the FDA?
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (K201840) received a 510(k) decision of Substantially Equivalent on November 4, 2020, 125 days after the submission was received.
What is the product code of K201840?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.