# K002788: Ksea Neuro-Fiberscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Oct 23, 2000 after 46 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K161112: KARL STORZ Flexible Video-Neuro-Endoscope System (2016), 6 descendants of its own
- 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

## Recalls of this device
- Aug 27, 2019 · Class II · Z-1531-2020: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information
- Aug 27, 2019 · Class II · Z-1530-2020: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information
- Aug 27, 2019 · Class II · Z-1532-2020: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information
- Feb 20, 2019 · Class II · Z-2425-2019: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

Source page: https://510kreport.com/device/K002788
Methodology: https://510kreport.com/methodology