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FDA 510(k)

VELA XL

K-Number: K103654 · 2011-04-06

ApplicantStarmedtec GmbH
Decision Date2011-04-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VELA 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 2011-04-06 under 510(k) number K103654. 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 VELA XL?

VELA XL is a medical device that received FDA 510(k) clearance on 2011-04-06. The listed applicant is Starmedtec GmbH. The 510(k) number is K103654.

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

VELA XL received FDA 510(k) clearance on 2011-04-06, under 510(k) number K103654.

Who is the listed applicant for VELA 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 VELA XL?

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

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 QIK111475AURIGA XL

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Official Source

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