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FDA 510(k)

MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22

K-Number: K080550 · 2008-06-10

ApplicantMinos Medical
Decision Date2008-06-10
Product CodeODB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 is the device name listed in this FDA 510(k) record. The listed applicant is Minos Medical. It received FDA 510(k) clearance on 2008-06-10 under 510(k) number K080550. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22?

MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 is a medical device that received FDA 510(k) clearance on 2008-06-10. The listed applicant is Minos Medical. The 510(k) number is K080550.

When did MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 receive FDA 510(k) clearance?

MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 received FDA 510(k) clearance on 2008-06-10, under 510(k) number K080550.

Who is the listed applicant for MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22?

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

What is the FDA product code for MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22?

The FDA product code for MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 is ODB.

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Related Devices (Code: ODB)

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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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