# K200514: Cardioblate Gemini-s Surgical Ablation Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Jun 3, 2020 after 93 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K942299 (1995). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K223508: Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device (2022), 0 descendants of its own

## Recalls of this device
- Apr 20, 2022 · Class II · Z-1131-2022: Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

## Indications for use
The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) 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/K200514
Methodology: https://510kreport.com/methodology