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FDA 510(k)

AURIGA XL

K-Number: K111475 · 2011-09-28

ApplicantStarmedtec GmbH
Decision Date2011-09-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AURIGA XL is the device name listed in this FDA 510(k) record. The listed applicant is Starmedtec GmbH. It received FDA 510(k) clearance on 2011-09-28 under 510(k) number K111475. 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 AURIGA XL?

AURIGA XL is a medical device that received FDA 510(k) clearance on 2011-09-28. The listed applicant is Starmedtec GmbH. The 510(k) number is K111475.

When did AURIGA XL receive FDA 510(k) clearance?

AURIGA XL received FDA 510(k) clearance on 2011-09-28, under 510(k) number K111475.

Who is the listed applicant for AURIGA XL?

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

What is the FDA product code for AURIGA XL?

The FDA product code for AURIGA XL is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Starmedtec GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121570AURIGA QIK103654VELA XL

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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