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FDA 510(k)

Eclipse DermaFlex Cannula

K-Number: K200017 · 2020-11-05

ApplicantEclipse Medcorp, LLC
Decision Date2020-11-05
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Eclipse DermaFlex Cannula 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 2020-11-05 under 510(k) number K200017. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse DermaFlex Cannula?

Eclipse DermaFlex Cannula is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Eclipse Medcorp, LLC. The 510(k) number is K200017.

When did Eclipse DermaFlex Cannula receive FDA 510(k) clearance?

Eclipse DermaFlex Cannula received FDA 510(k) clearance on 2020-11-05, under 510(k) number K200017.

Who is the listed applicant for Eclipse DermaFlex Cannula?

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 Eclipse DermaFlex Cannula?

The FDA product code for Eclipse DermaFlex Cannula is FMI.

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.

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Official Source

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