# K161112: KARL STORZ Flexible Video-Neuro-Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Sep 17, 2016 after 150 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: 1 generation back to K002788 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002788: Ksea Neuro-Fiberscope, KARL STORZ Endoscopy-America, Inc. (2000) Summary page 4.

## Most influential descendants
- K180270: Cellvizio 100 Series Systems with Confocal Miniprobes (2018), 5 descendants of its own
- K191144: Cellvizio 100 Series System with Confocal Miniprobes (2020), 2 descendants of its own
- K181116: Convivo (2018), 1 descendant of its own
- K243711: Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (2025), 0 descendants of its own
- K211156: CONVIVO In Vivo Pathology Suite (2021), 0 descendants of its own

## Indications for use
The KARL STORZ Flexible Video-Neuro-Endoscope System is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration.

Source page: https://510kreport.com/device/K161112
Methodology: https://510kreport.com/methodology