Data / Medical devices / United States / Rebound Therapeutics, Corporation
Rebound Therapeutics, Corporation: FDA-registered device maker in Irvine, CA, United States, 5 510(k) clearances
Rebound Therapeutics, Corporation is registered with the FDA (registration 3013505638) in Irvine, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 9, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013505638
- Address
- 13900 Alton Parkway Suite 120, Irvine, CA, United States, 92618
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Manufacturer
- First device listed
- October 8, 2019
- Registered through
- 2026
- Brand names listed
- ASX9/100, ASX9/130, ASX9/70, AURORA Evacuator + Coag, AURORA Surgiscope System, Aurora Evacuator, Aurora Surgiscope System, ICB/ASX15
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Manufacturer | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2025 | K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | GWG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 27, 2023 | K232618 | Aurora Surgiscope System | GWG | Substantially Equivalent | Rebound Therapeutics Corporation | accessdata.fda.gov |
| December 2, 2021 | K203745 | AURORA Evacuator +Coag | GEI | Substantially Equivalent | Rebound Therapeutics | accessdata.fda.gov |
| December 6, 2019 | K191861 | Aurora Surgiscope System | GWG | Substantially Equivalent | Rebound Therapeutics | accessdata.fda.gov |
| February 12, 2019 | K190075 | Aurora Evacuator | GEI | Substantially Equivalent | Rebound Therapeutics | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Endoscope, Neurological
- All makers of Retractor, Self-Retaining, For Neurosurgery
Updated April 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.