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FDA 510(k)

SKOUT Software

K-Number: K213686 · 2022-08-12

ApplicantIterative Scopes, Inc.
Decision Date2022-08-12
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKOUT Software is a medical device manufactured by Iterative Scopes, Inc.. It received FDA 510(k) clearance on 2022-08-12 under approval number K213686. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKOUT Software?

SKOUT Software is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by Iterative Scopes, Inc.. The 510(k) number is K213686.

When was SKOUT Software approved by the FDA?

SKOUT Software received FDA 510(k) clearance on 2022-08-12, under approval number K213686.

What company makes SKOUT Software?

SKOUT Software is manufactured by Iterative Scopes, Inc..

What is the FDA product code for SKOUT Software?

The FDA product code for SKOUT Software is QNP.

Other Devices by Iterative Scopes, Inc.

K230658SKOUT® system K241508SKOUT® system K240781SKOUT® system

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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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