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FDA 510(k)

SKOUT® system

K-Number: K230658 · 2023-04-07

ApplicantIterative Scopes, Inc.
Decision Date2023-04-07
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKOUT® system is a medical device manufactured by Iterative Scopes, Inc.. It received FDA 510(k) clearance on 2023-04-07 under approval number K230658. 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 2023-04-07. It is manufactured by Iterative Scopes, Inc.. The 510(k) number is K230658.

When was SKOUT® system approved by the FDA?

SKOUT® system received FDA 510(k) clearance on 2023-04-07, under approval number K230658.

What company makes SKOUT® system?

SKOUT® system is manufactured by Iterative Scopes, Inc..

What is the FDA product code for SKOUT® system?

The FDA product code for SKOUT® system is QNP.

Other Devices by Iterative Scopes, Inc.

K213686SKOUT Software K241508SKOUT® system K240781SKOUT® 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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