# K021050: Ksea Neuroendoscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jun 26, 2002 after 86 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
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K180146: KARL STORZ ICG Imaging System (2018), 30 descendants of its own
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own
- K214046: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (2022), 14 descendants of its own
- K221611: 780 nm L11 LED Light Source with AIM (2022), 10 descendants of its own
- K230216: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (2023), 8 descendants of its own

## Indications for use
The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery. ThNeuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery. The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures. The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.

Source page: https://510kreport.com/device/K021050
Methodology: https://510kreport.com/methodology