# K250752: AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Apr 9, 2025 after 28 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002931 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201840: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box), Rebound Therapeutics (2020) Summary page 5.

## Indications for use
The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic, and/or therapeutic procedures, such as ventriculostomies, biopsies and removal of cysts, tumors, and other obstructions.

Source page: https://510kreport.com/device/K250752
Methodology: https://510kreport.com/methodology