SKOUT® system— 510(k) K241508

Substantially Equivalent

Iterative Scopes, Inc.

FDA 510(k) clearance K241508 for SKOUT® system, Substantially Equivalent on 2024-07-03. Applicant: Iterative Scopes, Inc..

Clearance details

Applicant: Iterative Scopes, Inc.
Product code: Code QNP
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-28
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, US

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