FreezeSpray TA
FDA 510(k) K261684 · Cryosurgery, Inc.
510(k) numberK261684
Submission
- Device name
- FreezeSpray TA
- Applicant
- Cryosurgery, Inc.
Nashville, TN, US - Received
- May 21, 2026
- Decision date
- September 5, 2026
- 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 |
|---|---|---|---|
| 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 |
| K203661 | CRYO Arctic, CRYO PenguinMLY · Traditional | Cryoscience North America, Inc. | 05/25/2022SE |
| 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 |
More from Gebauer Company
| 510(k) | Device | Decision |
|---|---|---|
| K253000 | CryoFreeze Wart and Skin Tag RemoverGEH · Special | 10/16/2025SE |
| K252903 | Verruca-Freeze H PlusGEH · Special | 10/10/2025SE |
| K243487 | CryoFreeze Wart and Skin Tag RemoverGEH · Traditional | 03/13/2025SE |
| K243454 | Verruca-Freeze HGEH · Special | 12/03/2024SE |
| K233347 | Verruca-Freeze® HGEH · Traditional | 12/04/2023SE |
| K982506 | Verruca-Freeze Cryosurgery Delivery SystemGEH · Traditional | 01/27/1999SE |
| K955083 | Verruca-Freeze Cryosurgical Delivery System (Modification)GEH · Traditional | 02/08/1996SE |
| K944221 | Verruca-Freeze(Tm) Cryosurgical Delivery Syst, ModifiedGEH · Traditional | 12/15/1994SE |
Questions and answers
When was FreezeSpray TA cleared by the FDA?
FreezeSpray TA (K261684) received a 510(k) decision of Substantially Equivalent on September 5, 2026, 107 days after the submission was received.
What is the product code of K261684?
The FDA product code is MLY – Vapocoolant Device, a Unclassified device.