K250752 is an FDA 510(k) clearance for the AURORA® Surgiscope® System (ASX15/60). This device is classified as a Endoscope, Neurological (Class II - Special Controls, product code GWG).
Submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on April 9, 2025, 28 days after receiving the submission on March 12, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1480. 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)..
| 510(k) Number | K250752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2025 |
| Decision Date | April 09, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWG — Endoscope, Neurological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1480 |
| Definition | 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). |