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FDA 510(k)

ACCUTRAC

K-Number: K110686 · 2011-03-28

ApplicantBoston Scientific Corp
Decision Date2011-03-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCUTRAC is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2011-03-28 under 510(k) number K110686. 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 ACCUTRAC?

ACCUTRAC is a medical device that received FDA 510(k) clearance on 2011-03-28. The listed applicant is Boston Scientific Corp. The 510(k) number is K110686.

When did ACCUTRAC receive FDA 510(k) clearance?

ACCUTRAC received FDA 510(k) clearance on 2011-03-28, under 510(k) number K110686.

Who is the listed applicant for ACCUTRAC?

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

What is the FDA product code for ACCUTRAC?

The FDA product code for ACCUTRAC 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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