CRYO Arctic, CRYO Penguin
FDA 510(k) K203661 · Cryoscience North America, Inc.
510(k) numberK203661
Submission
- Device name
- CRYO Arctic, CRYO Penguin
- Applicant
- Cryoscience North America, Inc.
Houston, TX, US - Received
- December 15, 2020
- Decision date
- May 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLY – Vapocoolant Device
- Device class
- Unclassified
Other 510(k)s with product code MLY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261684 | FreezeSpray TAMLY · Traditional | Cryosurgery, Inc. | 09/05/2026SE |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 08/27/2026SE |
| K243654 | DentalJectMLY · Traditional | Vapocoolshot, Inc. | 05/30/2025SE |
| K232674 | PainFreeze IIMLY · Traditional | Nuance Medical, LLC | 02/12/2024SE |
| K202782 | num VapocoolantMLY · Traditional | 623 Medical, LLC | 12/21/2020SE |
| K201248 | Syringe Holder accessoryMLY · Traditional | Vapocoolshot, Inc. | 08/12/2020SE |
| K193349 | Vapocoolshot MistMLY · Traditional | Vapocoolshot, Inc. | 04/14/2020SE |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…MLY · Traditional | Gebauer Company | 05/07/2019SE |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream…MLY · Traditional | Itw Contamination Control Electronics | 04/19/2018SE |
| K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 10/27/2017SE |
Questions and answers
When was CRYO Arctic, CRYO Penguin cleared by the FDA?
CRYO Arctic, CRYO Penguin (K203661) received a 510(k) decision of Substantially Equivalent on May 25, 2022, 526 days after the submission was received.
What is the product code of K203661?
The FDA product code is MLY – Vapocoolant Device, a Unclassified device.