MicroPen EVO
Powered Microneedle Device
Eclipse MedCorp, LLC
The following data is part of a premarket notification filed by Eclipse Medcorp, Llc with the FDA for Micropen Evo.
Pre-market Notification Details
| Device ID | K203144 |
| 510k Number | K203144 |
| Device Name: | MicroPen EVO |
| Classification | Powered Microneedle Device |
| Applicant | Eclipse MedCorp, LLC 5916 Stone Creek Drive The Colony, TX 75056 |
| Contact | Julie Summerville |
| Correspondent | Julie Summerville Eclipse MedCorp, LLC 5916 Stone Creek Drive The Colony, TX 75056 |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-21 |
| Decision Date | 2021-05-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853602008598 | K203144 | 000 |
| 10853602008397 | K203144 | 000 |
Trademark Results [MicroPen EVO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROPEN EVO 90465541 not registered Live/Pending |
Eclipse MedCorp, LLC 2021-01-14 |
 MICROPEN EVO 90465512 not registered Live/Pending |
Eclipse MedCorp, LLC 2021-01-14 |
 MICROPEN EVO 88731960 not registered Live/Pending |
Eclipse MedCorp, LLC 2019-12-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.