ATRICURE CRYO MODULE
FDA 510(k) clearance K111042 · decided 2011-05-26
Clearance details
- K-number
- K111042
- Device name
- ATRICURE CRYO MODULE
- Applicant
- AtriCure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-15
- Decision date
- 2011-05-26
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Chester, OH, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch AtriCure
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EPi-Sense ST Coagulation System (P200002/S013) | AtriCure, Inc. | 2025-11-14 |
| EPi-Sense Guided Coagulation System (P200002/S012) | AtriCure, Inc. | 2025-10-07 |
| Synergy Ablation System (P100046/S019) | AtriCure, Inc. | 2025-06-17 |
| EPi-Sense Guided Coagulation System (P200002/S011) | AtriCure, Inc. | 2025-06-17 |
| EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010) | AtriCure, Inc. | 2025-03-03 |
| Cannula with Guide (P200002/S009) | AtriCure, Inc. | 2024-08-28 |
| Synergy Ablation System (P100046/S018) | AtriCure, Inc. | 2024-03-15 |
| EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S008) | AtriCure, Inc. | 2023-12-11 |