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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 the device name listed in this FDA 510(k) record. The listed applicant is Gi Scientific, LLC. It received FDA 510(k) clearance on 2019-10-08 under 510(k) 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. The listed applicant is Gi Scientific, LLC. The 510(k) number is K183171.

When did ScopeSeal Duodenoscope Protective Device receive FDA 510(k) clearance?

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

Who is the listed applicant for ScopeSeal Duodenoscope Protective Device?

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

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

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

Related Devices (Code: ODB)

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

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

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