Atlas FDA

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

FDA 510(k) clearance K223508 · decided 2022-12-22

Clearance details

K-number
K223508
Device name
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2022-11-22
Decision date
2022-12-22
Days to decision
30 days
Clearance type
Special
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056)AtriCure, Inc.2025-07-24
Isolator Synergy EnCapture Ablation System (EMH) (K234151)AtriCure, Inc.2024-08-27
Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (K221358)AtriCure, Inc.2022-12-30
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (K210477)AtriCure, Inc.2021-07-26
AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)AtriCure, Inc.2021-05-28
Cardioblate Gemini-s Surgical Ablation Device (K200514)Medtronic2020-06-03
EPi-Sense Guided Coagulation System with VisiTrax (K193162)AtriCure, Inc.2019-12-13
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125)AtriCure, Inc.2019-11-04
Cardioblate CryoFlex Surgical Ablation System (K191526)Medtronic, Inc.2019-10-01
Coolrail Linear Pen (K190587)AtriCure, Inc.2019-07-24
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device (K190623)Medtronic2019-05-30
COBRA Fusion Ablation System (K190151)AtriCure, Inc.2019-02-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar (P010015/S589)Medtronic, Inc.2026-07-31
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED (P980035/S846)Medtronic, Inc.2026-07-31
Aurora EV ICD (DVEA3E4) (P220012/S074)Medtronic, Inc.2026-07-31
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S229)Medtronic, Inc.2026-07-31