# K162410: TIPCAM 1S 3D System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Mar 2, 2017 after 185 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 K874215 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082667: Visionsense Stereoscopic Vision System (VS System), Visionsense, Ltd. (2008) 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 to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures. IMAGE1 S is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

Source page: https://510kreport.com/device/K162410
Methodology: https://510kreport.com/methodology