# K232618: Aurora Surgiscope System

- Pathway: 510(k) (Traditional)
- Applicant: Rebound Therapeutics Corporation
- Decided: Oct 27, 2023 after 59 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: 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.

## Recalls of this device
- Jun 7, 2024 · Class II · Z-2331-2024: Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

## 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/K232618
Methodology: https://510kreport.com/methodology