# K262547: KARL STORZ TIPCAM1 Rubina

- Pathway: 510(k) (Traditional)
- Applicant: KALR STORZ SE & Co. KG
- Decided: Sep 21, 2026 after 60 days
- Product code: OWN (Confocal Optical Imaging)
- 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: 20 generations back to K930667 (1994). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212695: KARL STORZ ICG Imaging System, Karl Storz Endoscopy America (2021) Summary page 5.

## Indications for use
The TIPCAM1 Rubina videoscope 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 cavities, including gynecological and urological anatomy. Indicated for selected thoracoscopically-assisted cardiac surgical procedures, such as: - Mitral valve repair - IMA mobilization for cardiac revascularization - Patent foramen ovale closure - Atrial septal defect repair - Left atrial appendage closure/occlusion - Atrial myxoma excision - Mitral valve replacement - Tricuspid valve repair - Epicardial pacing lead placement

Source page: https://510kreport.com/device/K262547
Methodology: https://510kreport.com/methodology