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FDA 510(k)

Scope Antifogging System

K-Number: K182080 · 2018-09-19

ApplicantXodus Medical, Inc.
Decision Date2018-09-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Scope Antifogging System is the device name listed in this FDA 510(k) record. The listed applicant is Xodus Medical, Inc.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K182080. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scope Antifogging System?

Scope Antifogging System is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Xodus Medical, Inc.. The 510(k) number is K182080.

When did Scope Antifogging System receive FDA 510(k) clearance?

Scope Antifogging System received FDA 510(k) clearance on 2018-09-19, under 510(k) number K182080.

Who is the listed applicant for Scope Antifogging System?

The FDA 510(k) record lists Xodus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scope Antifogging System?

The FDA product code for Scope Antifogging System is GCJ.

Other records listing Xodus Medical, 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.

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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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