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FDA 510(k)

TRIPLEX ER. YAG / ND: YAG SYSTEM

K-Number: K110502 · 2011-04-27

ApplicantSandstone Medical Technologies, LLC
Decision Date2011-04-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIPLEX ER. YAG / ND: YAG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sandstone Medical Technologies, LLC. It received FDA 510(k) clearance on 2011-04-27 under 510(k) number K110502. 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 TRIPLEX ER. YAG / ND: YAG SYSTEM?

TRIPLEX ER. YAG / ND: YAG SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-27. The listed applicant is Sandstone Medical Technologies, LLC. The 510(k) number is K110502.

When did TRIPLEX ER. YAG / ND: YAG SYSTEM receive FDA 510(k) clearance?

TRIPLEX ER. YAG / ND: YAG SYSTEM received FDA 510(k) clearance on 2011-04-27, under 510(k) number K110502.

Who is the listed applicant for TRIPLEX ER. YAG / ND: YAG SYSTEM?

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

What is the FDA product code for TRIPLEX ER. YAG / ND: YAG SYSTEM?

The FDA product code for TRIPLEX ER. YAG / ND: YAG SYSTEM 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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