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FDA 510(k)

GELPOINT PATH

K-Number: K110792 · 2011-05-23

ApplicantApplied Medical Resources Corp.
Decision Date2011-05-23
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GELPOINT PATH is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2011-05-23 under 510(k) number K110792. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELPOINT PATH?

GELPOINT PATH is a medical device that received FDA 510(k) clearance on 2011-05-23. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K110792.

When did GELPOINT PATH receive FDA 510(k) clearance?

GELPOINT PATH received FDA 510(k) clearance on 2011-05-23, under 510(k) number K110792.

Who is the listed applicant for GELPOINT PATH?

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

What is the FDA product code for GELPOINT PATH?

The FDA product code for GELPOINT PATH is FER.

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Other records listing Applied Medical Resources Corp. as applicant

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Related Devices (Code: FER)

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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