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FDA 510(k)

ENDOSEE MODEL 8000 U-SCOPE

K-Number: K123151 · 2013-03-08

ApplicantEndosee Corp
Decision Date2013-03-08
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOSEE MODEL 8000 U-SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Endosee Corp. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K123151. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSEE MODEL 8000 U-SCOPE?

ENDOSEE MODEL 8000 U-SCOPE is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Endosee Corp. The 510(k) number is K123151.

When did ENDOSEE MODEL 8000 U-SCOPE receive FDA 510(k) clearance?

ENDOSEE MODEL 8000 U-SCOPE received FDA 510(k) clearance on 2013-03-08, under 510(k) number K123151.

Who is the listed applicant for ENDOSEE MODEL 8000 U-SCOPE?

The FDA 510(k) record lists Endosee Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSEE MODEL 8000 U-SCOPE?

The FDA product code for ENDOSEE MODEL 8000 U-SCOPE is HIH.

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Official Source

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

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