# K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE

- Pathway: 510(k) (Special)
- Applicant: Endocare, Inc.
- Decided: Jun 6, 2002 after 69 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: 1 generation back to K011040 (2001). 1 ancestor in all.
43 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011040: Cryocare Cardiac Surgical System, Endocare, Inc. (2001)

## Most influential descendants
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 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
- K043579: Atricure Bipolar System (2007), 18 descendants of its own
- K082074: Atricure CRYO1 Cryo-Ablation Probe (2009), 16 descendants of its own
- K111042: Atricure Cryo Module (2011), 14 descendants of its own

## Indications for use
The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis

Source page: https://510kreport.com/device/K021010
Methodology: https://510kreport.com/methodology