Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SKOUT® system

K-Number: K240781 · 2024-04-19

ApplicantIterative Scopes, Inc.
Decision Date2024-04-19
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 2024-04-19 under approval number K240781. 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 2024-04-19. It is manufactured by Iterative Scopes, Inc.. The 510(k) number is K240781.

When was SKOUT® system approved by the FDA?

SKOUT® system received FDA 510(k) clearance on 2024-04-19, under approval number K240781.

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 K230658SKOUT® system K241508SKOUT® 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.

↑