# K201840: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

- Pathway: 510(k) (Traditional)
- Applicant: Rebound Therapeutics
- Decided: Nov 4, 2020 after 125 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002931 (2000). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191861: Aurora Surgiscope System, Rebound Therapeutics (2019) Summary page 4.

## Most influential descendants
- K250752: AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (2025), 0 descendants of its own
- K232618: Aurora Surgiscope System (2023), 0 descendants of its own

## Recalls of this device
- Feb 6, 2025 · Class II · Z-1295-2025: Possibility for the obturator to break (separate).

## 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/K201840
Methodology: https://510kreport.com/methodology