# K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 20, 2015 after 263 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 37 ancestors in all.
7 later devices descend from it; 2 cite it directly.
3 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190, Olympus Medical Systems Corp. (2013) Summary page 4.

## Most influential descendants
- K201526: TIPCAM1 Rubina Video Endoscope System (2020), 5 descendants of its own
- 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

## Indications for use
3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use 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. IMAGE1 SPIES 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/K150525
Methodology: https://510kreport.com/methodology