C2 CryoBalloon Ablation System
FDA 510(k) K212814 · Pentax of America, Inc.
510(k) numberK212814
Submission
- Device name
- C2 CryoBalloon Ablation System
- Applicant
- Pentax of America, Inc.
Redwood, Ca, CA, US - Received
- September 3, 2021
- Decision date
- November 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
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| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH · Traditional | 07/24/2024SE |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…EOQ · Traditional | 01/18/2024SE |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…EOQ · Traditional | 01/12/2024SE |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14ODC · Traditional | 12/01/2023SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | 07/28/2023SE |
Questions and answers
When was C2 CryoBalloon Ablation System cleared by the FDA?
C2 CryoBalloon Ablation System (K212814) received a 510(k) decision of Substantially Equivalent on November 29, 2021, 87 days after the submission was received.
What is the product code of K212814?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.