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FDA 510(k)

SKOUT system

K-Number: K253664 · 2025-12-22

ApplicantIterative Health
Decision Date2025-12-22
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKOUT system is a medical device manufactured by Iterative Health. It received FDA 510(k) clearance on 2025-12-22 under approval number K253664. 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 system?

SKOUT system is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Iterative Health. The 510(k) number is K253664.

When was SKOUT system approved by the FDA?

SKOUT system received FDA 510(k) clearance on 2025-12-22, under approval number K253664.

What company makes SKOUT system?

SKOUT system is manufactured by Iterative Health.

What is the FDA product code for SKOUT system?

The FDA product code for SKOUT system is QNP.

Other Devices by Iterative Health

K251126SKOUT system

Related Devices (Code: QNP)

K211326EndoScreenerChengdu Wision Medical Device Co., Ltd. K211951GI GeniusCosmo Artificial Intelligence - Ai, Ltd. DEN200055GI GeniusCosmo Artificial Intelligence - Ai, Ltd. K213686SKOUT SoftwareIterative Scopes, Inc. K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation K223473ME-APDS™; MAGENTIQ-COLO™Magentiq Eye, Ltd.

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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