FDA 510(k)

SpyGlass DS and DS II Direct Visualization System

K-Number: K181439 · 2018-08-23

Decision Date2018-08-23

Product CodeFBN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SpyGlass DS and DS II Direct Visualization System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-08-23 under approval number K181439. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpyGlass DS and DS II Direct Visualization System?

SpyGlass DS and DS II Direct Visualization System is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K181439.

When was SpyGlass DS and DS II Direct Visualization System approved by the FDA?

SpyGlass DS and DS II Direct Visualization System received FDA 510(k) clearance on 2018-08-23, under approval number K181439.

What company makes SpyGlass DS and DS II Direct Visualization System?

SpyGlass DS and DS II Direct Visualization System is manufactured by Boston Scientific Corporation.

What is the FDA product code for SpyGlass DS and DS II Direct Visualization System?

The FDA product code for SpyGlass DS and DS II Direct Visualization System is FBN.

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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.