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FDA 510(k)

MicroPen EVO

K-Number: K212558 · 2021-11-24

ApplicantEclipse Medcorp, LLC
Decision Date2021-11-24
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MicroPen EVO is a medical device manufactured by Eclipse Medcorp, LLC. It received FDA 510(k) clearance on 2021-11-24 under approval number K212558. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroPen EVO?

MicroPen EVO is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Eclipse Medcorp, LLC. The 510(k) number is K212558.

When was MicroPen EVO approved by the FDA?

MicroPen EVO received FDA 510(k) clearance on 2021-11-24, under approval number K212558.

What company makes MicroPen EVO?

MicroPen EVO is manufactured by Eclipse Medcorp, LLC.

What is the FDA product code for MicroPen EVO?

The FDA product code for MicroPen EVO is QAI.

Other Devices by Eclipse Medcorp, LLC

K200017Eclipse DermaFlex Cannula K203144MicroPen EVO K213690Eclipse Blood Collection Set

Related Devices (Code: QAI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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