# K162880: TIPCAM 1S 3D System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Mar 16, 2017 after 153 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: 4 generations back to K002431 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131434: VS3 Stereoscopic High Definition Vision System, Visionsense, Ltd. (2013) Summary page 4.

## Indications for use
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures. IMAGE 1S is a camera control unit (CCU) for use with camera heads of videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

Source page: https://510kreport.com/device/K162880
Methodology: https://510kreport.com/methodology