Syringe Holder accessory
510(k) K201248
Syringe Holder accessory is a medical device (FDA unclassified; FDA product code MLY, Vapocoolant Device) made by Vapocoolshot, Inc, cleared under FDA 510(k) K201248 on 12 Aug 2020, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201248 | Date12 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K201248
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MLY
- FDA applicant
- Vapocoolshot, Inc.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201248
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Coolject 1-3cc Syringe Holder Nozzle Accessory VM01000-00 | VM01000-00 | 00860006961510 | No longer on the market | |
| Coolject 1-3cc Syringe Holder Nozzle Accessory VM01000-00 | VM01000-00 | 00860006961534 | No longer on the market | |
| CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory CJ01050-00 | CJ01050-00 / CJ01050-00 | 00860010587317 | On the market |
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