# K201526: TIPCAM1 Rubina Video Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America
- Decided: Nov 20, 2020 after 165 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: 11 generations back to K931154 (1993). 38 ancestors in all.
5 later devices descend from it; 1 cites it directly.
3 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link, KARL STORZ Endoscopy-America, Inc. (2015) Summary page 4.

## Most influential descendants
- K223759: Arthrex SynergyID Endoscopic Imaging System (2023), 4 descendants of its own
- K233451: Arthrex Synergy Vision Endoscopic Imaging System (2024), 3 descendants of its own
- K241361: Arthrex Synergy Vision Endoscopic Imaging System (2024), 2 descendants of its own
- K250728: Arthrex Synergy Vision Endoscopic Imaging System (2025), 1 descendant of its own
- K251994: Arthrex Synergy Vision Imaging System (2025), 0 descendants of its own

## Indications for use
The TIPCAM®]1 Rubina Video Endoscope System is intended to be used together with the camera control unit during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological and urological anatomy.

Source page: https://510kreport.com/device/K201526
Methodology: https://510kreport.com/methodology