C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
FDA 510(k) K190194 · Pentax Medical, A Division of Pentax of America, Inc.
510(k) numberK190194
Submission
- Device name
- C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- Applicant
- Pentax Medical, A Division of Pentax of America, Inc.
Redwood, Ca, CA, US - Received
- February 4, 2019
- Decision date
- May 31, 2019
- 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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| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
More from Recensmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193036 | C2 CryoBalloon EndoGripOCX · Special | 11/22/2019SE |
Questions and answers
When was C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge cleared by the FDA?
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K190194) received a 510(k) decision of Substantially Equivalent on May 31, 2019, 116 days after the submission was received.
What is the product code of K190194?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.