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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 the device name listed in this FDA 510(k) record. The listed applicant is Eclipse Medcorp, LLC. It received FDA 510(k) clearance on 2021-11-24 under 510(k) 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. The listed applicant is Eclipse Medcorp, LLC. The 510(k) number is K212558.

When did MicroPen EVO receive FDA 510(k) clearance?

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

Who is the listed applicant for MicroPen EVO?

The FDA 510(k) record lists Eclipse Medcorp, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MicroPen EVO?

The FDA product code for MicroPen EVO is QAI.

Other records listing Eclipse Medcorp, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213690Eclipse Blood Collection SetK203144MicroPen EVOK200017Eclipse DermaFlex Cannula

Related Devices (Code: QAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252591Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd.K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.

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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