# K193235: Telepack +

- Pathway: 510(k) (Special)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Dec 20, 2019 after 25 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070716 (2007). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182696: Telepack X LED, KARL STORZ Endoscopy-America, Inc. (2018) Summary page 4.

## Most influential descendants
- K221174: Telepack + (2022), 0 descendants of its own

## Indications for use
The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.

Source page: https://510kreport.com/device/K193235
Methodology: https://510kreport.com/methodology