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FDA 510(k)

Roth Net Retriever Product Line

K-Number: K182909 · 2018-11-21

Decision Date2018-11-21
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Roth Net Retriever Product Line is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182909. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Roth Net Retriever Product Line?

Roth Net Retriever Product Line is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K182909.

When did Roth Net Retriever Product Line receive FDA 510(k) clearance?

Roth Net Retriever Product Line received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182909.

Who is the listed applicant for Roth Net Retriever Product Line?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Roth Net Retriever Product Line?

The FDA product code for Roth Net Retriever Product Line is FDI.

Other records listing United States Endoscopy Group, Inc. 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.

View all 10 devices →

Related Devices (Code: FDI)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.