Aurora Surgiscope System
FDA 510(k) K232618 · Rebound Therapeutics Corporation
510(k) numberK232618
Submission
- Device name
- Aurora Surgiscope System
- Applicant
- Rebound Therapeutics Corporation
Irvine, CA, US - Received
- August 29, 2023
- Decision date
- October 27, 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).
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 |
| 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 |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…GWG · Traditional | Stryker | 08/06/2021SE |
More from Stryker
| 510(k) | Device | Decision |
|---|---|---|
| K203745 | AURORA Evacuator +CoagGEI · Traditional | 12/02/2021SE |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)GWG · Traditional | 11/04/2020SE |
| 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 cleared by the FDA?
Aurora Surgiscope System (K232618) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 59 days after the submission was received.
What is the product code of K232618?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.