FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
K Number: K233170
·
Decision Oct 26, 2023
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
22
Applicant Total
59
Review Days
29
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Basic Information
- Device Name
- cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
- K Number
- K233170
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AtriCure, Inc.
- Date Received
- September 27, 2023
- Decision Date
- October 26, 2023
- Product Code
- GXH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXH | Device, Surgical, Cryogenic | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXH), ordered by most recent decision date.
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AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
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Other Clearances by AtriCure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | Jul 24, 2025 | Substantially Equivalent |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | Apr 10, 2025 | Substantially Equivalent |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | Jan 15, 2025 | Substantially Equivalent |
| K243157 | AtriCure cryoICE BOX (ACM) | Oct 29, 2024 | Substantially Equivalent |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | Aug 27, 2024 | Substantially Equivalent |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | Jul 29, 2024 | Substantially Equivalent |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | Feb 13, 2024 | Substantially Equivalent |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | Nov 2, 2023 | Substantially Equivalent |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | Dec 30, 2022 | Substantially Equivalent |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | Jul 26, 2021 | Substantially Equivalent |