MLYUnclassified
Vapocoolant Device
Unknown
MLY is the FDA product code for Vapocoolant Device. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- MLY
- Device name
- Vapocoolant Device
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 25
- Ingested recalls
- 7
Clearances, product code MLY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code MLY| Applicant | Clearances |
|---|---|
| Gebauer Co | 9 |
| Nuance Medical, LLC | 3 |
| Vapocoolshot, Inc | 3 |
| 623 Medical | 1 |
| Ari | 1 |
| Cryonic Medical North America | 1 |
| Cryoscience North America, Inc. | 1 |
| Cryosurgery, Inc. | 1 |
| Dukal Corp. | 1 |
| Gebauer Company | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.