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FDA 510(k)

SKOUT® system

K-Number: K241508 · 2024-07-03

ApplicantIterative Scopes, Inc.
Decision Date2024-07-03
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKOUT® system is the device name listed in this FDA 510(k) record. The listed applicant is Iterative Scopes, Inc.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K241508. 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 2024-07-03. The listed applicant is Iterative Scopes, Inc.. The 510(k) number is K241508.

When did SKOUT® system receive FDA 510(k) clearance?

SKOUT® system received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241508.

Who is the listed applicant for SKOUT® system?

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

What is the FDA product code for SKOUT® system?

The FDA product code for SKOUT® system is QNP.

Other records listing Iterative Scopes, 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.

K240781SKOUT® systemK230658SKOUT® systemK213686SKOUT Software

Related Devices (Code: QNP)

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.

K260567EW10-EC02 Endoscopy Support ProgramFujifilm CorporationK252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT systemIterative HealthK252178MAGENTIQ-COLO (ME-APDS)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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