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FDA 510(k)

ENDO SMARTCAP

K-Number: K093665 · 2009-12-15

ApplicantByrne Medical, Inc.
Decision Date2009-12-15
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO SMARTCAP is the device name listed in this FDA 510(k) record. The listed applicant is Byrne Medical, Inc.. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K093665. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO SMARTCAP?

ENDO SMARTCAP is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K093665.

When did ENDO SMARTCAP receive FDA 510(k) clearance?

ENDO SMARTCAP received FDA 510(k) clearance on 2009-12-15, under 510(k) number K093665.

Who is the listed applicant for ENDO SMARTCAP?

The FDA 510(k) record lists Byrne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO SMARTCAP?

The FDA product code for ENDO SMARTCAP is FAJ.

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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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