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FDA 510(k)

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock

K-Number: K170215 · 2017-04-19

ApplicantPatient Pocket, LLC
Decision Date2017-04-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is the device name listed in this FDA 510(k) record. The listed applicant is Patient Pocket, LLC. It received FDA 510(k) clearance on 2017-04-19 under 510(k) number K170215. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is a medical device that received FDA 510(k) clearance on 2017-04-19. The listed applicant is Patient Pocket, LLC. The 510(k) number is K170215.

When did LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock receive FDA 510(k) clearance?

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock received FDA 510(k) clearance on 2017-04-19, under 510(k) number K170215.

Who is the listed applicant for LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

The FDA 510(k) record lists Patient Pocket, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

The FDA product code for LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is GEX. This falls under the Gastroenterology category.

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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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