# K223508: Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 22, 2022 after 30 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K942299 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121767: Cardioblate Gemini Surgical Ablation Device, Medtronic, Inc. (2012) Summary page 4.
- K200514: Cardioblate Gemini-s Surgical Ablation Device, Medtronic (2020) Summary page 4.

## Indications for use
The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

Source page: https://510kreport.com/device/K223508
Methodology: https://510kreport.com/methodology