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FDA 510(k)

ScopeSeal Duodenoscope Protective Device

K-Number: K183171 · 2019-10-08

ApplicantGi Scientific, LLC
Decision Date2019-10-08
Product CodeODB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ScopeSeal Duodenoscope Protective Device is a medical device manufactured by Gi Scientific, LLC. It received FDA 510(k) clearance on 2019-10-08 under approval number K183171. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScopeSeal Duodenoscope Protective Device?

ScopeSeal Duodenoscope Protective Device is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Gi Scientific, LLC. The 510(k) number is K183171.

When was ScopeSeal Duodenoscope Protective Device approved by the FDA?

ScopeSeal Duodenoscope Protective Device received FDA 510(k) clearance on 2019-10-08, under approval number K183171.

What company makes ScopeSeal Duodenoscope Protective Device?

ScopeSeal Duodenoscope Protective Device is manufactured by Gi Scientific, LLC.

What is the FDA product code for ScopeSeal Duodenoscope Protective Device?

The FDA product code for ScopeSeal Duodenoscope Protective Device is ODB.

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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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