FDA 510(k)

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

K-Number: K231549 · 2023-06-29

Decision Date2023-06-29

Product CodeOTN

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231549. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Boston Scientific Corporation. The 510(k) number is K231549.

When did Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System receive FDA 510(k) clearance?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231549.

Who is the listed applicant for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

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

What is the FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is OTN.

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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.