# K221004: HOPKINS Telescopes

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Dec 20, 2022 after 259 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 1 generation back to K935279 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935279: Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid Autoclavable Telescope, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 4.

## Most influential descendants
- K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (2023), 2 descendants of its own
- K254242: KARL STORZ ICG Imaging System with RUBINA® Lens (2026), 0 descendants of its own
- K253972: IMAGE1 (TC400US); X-to-4U Adapter (TC040) (2026), 0 descendants of its own

## Indications for use
The HOPKINS Telescopes are intended to provide visualization during laparoscopy, thoracoscopy and general surgery in adults and pediatrics.

Source page: https://510kreport.com/device/K221004
Methodology: https://510kreport.com/methodology