CryOmega Flexx
FDA 510(k) K172769 · Cryoconcepts LP
510(k) numberK172769
Submission
- Device name
- CryOmega Flexx
- Applicant
- Cryoconcepts LP
Bethlehem, PA, US - Received
- September 13, 2017
- Decision date
- November 30, 2017
- 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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| K190407 | CryoLabGEH · Traditional | 04/22/2019SE |
| K183601 | CryoTouchGEH · Traditional | 04/18/2019SE |
Questions and answers
When was CryOmega Flexx cleared by the FDA?
CryOmega Flexx (K172769) received a 510(k) decision of Substantially Equivalent on November 30, 2017, 78 days after the submission was received.
What is the product code of K172769?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.