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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 a medical device manufactured by Xodus Medical, Inc.. It received FDA 510(k) clearance on 2018-09-19 under approval 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. It is manufactured by Xodus Medical, Inc.. The 510(k) number is K182080.

When was Scope Antifogging System approved by the FDA?

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

What company makes Scope Antifogging System?

Scope Antifogging System is manufactured by Xodus Medical, Inc..

What is the FDA product code for Scope Antifogging System?

The FDA product code for Scope Antifogging System is GCJ.

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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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