Device class
—
Regulation —
Total clearances
7
2020-12-23 → 2025-04-10
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
AtriCure, Inc.
|
4 |
0 |
2025-04-10 |
|
Pacira Biosciences, Inc. |
2 |
0 |
2024-12-26 |
|
Pacira Pharmaceuticals, Inc. |
1 |
0 |
2021-09-10 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 64999 |
CPT
|
— |
Low
|
Unlisted procedure, nervous system; cryosurgical devices lack specific CPT codes and are context-dependent |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-04-10 |
K250371 |
AtriCure, Inc.
|
cryoICE cryoXT cryoablation probe (cryoXT) |
| 2024-12-26 |
K243677 |
Pacira Biosciences, Inc.
|
iovera° System |
| 2024-10-29 |
K243157 |
AtriCure, Inc.
|
AtriCure cryoICE BOX (ACM) |
| 2023-10-26 |
K233170 |
AtriCure, Inc.
|
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) |
| 2022-05-20 |
K220656 |
Pacira Biosciences, Inc.
|
iovera System |
| 2021-09-10 |
K211334 |
Pacira Pharmaceuticals, Inc.
|
Iovera System |
| 2020-12-23 |
K200697 |
AtriCure, Inc.
|
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) |