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FDA 510(k)

I-ENDO DUAL

K-Number: K111623 · 2012-01-10

ApplicantSatelec - Acteon Group
Decision Date2012-01-10
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-ENDO DUAL is the device name listed in this FDA 510(k) record. The listed applicant is Satelec - Acteon Group. It received FDA 510(k) clearance on 2012-01-10 under 510(k) number K111623. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-ENDO DUAL?

I-ENDO DUAL is a medical device that received FDA 510(k) clearance on 2012-01-10. The listed applicant is Satelec - Acteon Group. The 510(k) number is K111623.

When did I-ENDO DUAL receive FDA 510(k) clearance?

I-ENDO DUAL received FDA 510(k) clearance on 2012-01-10, under 510(k) number K111623.

Who is the listed applicant for I-ENDO DUAL?

The FDA 510(k) record lists Satelec - Acteon Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-ENDO DUAL?

The FDA product code for I-ENDO DUAL is EBW.

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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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