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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 a medical device manufactured by Patient Pocket, LLC. It received FDA 510(k) clearance on 2017-04-19 under approval 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. It is manufactured by Patient Pocket, LLC. The 510(k) number is K170215.

When was LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock approved by the FDA?

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

What company makes LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is manufactured by Patient Pocket, LLC.

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

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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