# K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 - Pathway: 510(k) (Special) - Applicant: AtriCure, Inc. - Decided: Apr 19, 2002 after 29 days - Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories) - 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: 5 generations back to K942299 (1995). 31 ancestors in all. 90 later devices descend from it; 9 cite it directly. 0 of 122 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K011722: Atricure Bipolar Coagulation System, AtriCure, Inc. (2001) Summary page 1. ## Cited in the summary but kept off the family tree - K010122: Continuous Flow Y-Tubing, G.U.-Tek (2001). Our OCR of the scanned summary read K010122, FDA’s number for Continuous Flow Y-Tubing (G.U.-Tek). Its FDA name has none of the distinctive words the summary uses for the device it names, “AtriCure Bipolar Coagulation System”. Kept off the family tree. Summary page 1. ## Most influential descendants - K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own - K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own - K022894: Epicor Medical Ablation System (2004), 23 descendants of its own - K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console (2006), 22 descendants of its own - K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1 (2004), 22 descendants of its own ## Indications for use The AtriCure Bipolar System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology and Urology surgical procedures. Source page: https://510kreport.com/device/K020919 Methodology: https://510kreport.com/methodology