# K011722: Atricure Bipolar Coagulation System

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Aug 30, 2001 after 87 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: 4 generations back to K942299 (1995). 30 ancestors in all.
92 later devices descend from it; 4 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973384: Ethicon Non-Stick Bipolar Forceps, ETHICON, Inc. (1997) Summary page 1.
- K992931: Non-Stick Bipolar Forceps, Silverglide Surgical Technologies (1999) Summary page 1.
- K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode, Rita Medical Systems (1999) Summary page 1.
- K000501: Electrosurgical Generator, Model S1, Somnus Medical Technologies, Inc. (2000)
- K950286: Symbiosis Bipolar Scissors, Symbiosis Corp. (1995) Summary page 1.
- K951387: Symbiosis Bipolar Scissors, Symbiosis Corp. (1995) Summary page 1.
- K945975: Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps, Everest Medical Corp. (1994) Summary page 1.
- K955001: Evershears Scissors, Bilap Probes, Bicoag Forceps, Everest Medical Corp. (1995) Summary page 1.
- K963930: CTS Midcab/SVH Bipolar Scissors, Cardiothoracic Systems, Inc. (1997) Summary page 1.
- K970496: Heartport Maze System: Cryoprobe Set, Heartport, Inc. (1997) Summary page 1.
- K980110: Endocre Cryocare Cryosurgical System, Endocare, Inc. (1998). Our OCR of the scanned summary read K880110, FDA’s number for Cystine Tryptic Medium W/Dextrose (Hardy Media). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EndoCare Cryocare Cryosurgical System”.
- K974320: Cryogen Cardiac Cryosurgical System, Cryogen, Inc. (1998) Summary page 1.
- K003050: Cryosurgical Unit and Accessories, Cryogen, Inc. (2000)
- K991517: Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, Galil Medical, Ltd. (1999) Summary page 1.
- K993965: Cryo-Hit, Galil Medical, Ltd. (2000) Summary page 1.

## Most influential descendants
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- 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

## Indications for use
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

Source page: https://510kreport.com/device/K011722
Methodology: https://510kreport.com/methodology