# K170462: KARL STORZ ShuntScope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: May 16, 2017 after 90 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003914: Medtronic PS Medical Neuropen Endoscope and Optical Accessories, Medtronic PS Medical (2001) Summary page 4.
- K002788: Ksea Neuro-Fiberscope, KARL STORZ Endoscopy-America, Inc. (2000) Summary page 4.

## Indications for use
The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population.

Source page: https://510kreport.com/device/K170462
Methodology: https://510kreport.com/methodology