Aurora Evacuator
FDA 510(k) K190075 · Rebound Therapeutics
510(k) numberK190075
Submission
- Device name
- Aurora Evacuator
- Applicant
- Rebound Therapeutics
Irvine, CA, US - Received
- January 16, 2019
- Decision date
- February 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 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 Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K232618 | Aurora Surgiscope SystemGWG · Traditional | 10/27/2023SE |
| 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 |
| K182211 | Aurora Surgiscope SystemGWG · Traditional | 01/18/2019SE |
| K180372 | Aurora EvacuatorGEI · Traditional | 04/09/2018SE |
Questions and answers
When was Aurora Evacuator cleared by the FDA?
Aurora Evacuator (K190075) received a 510(k) decision of Substantially Equivalent on February 12, 2019, 27 days after the submission was received.
What is the product code of K190075?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.