CT-STOR— 510(k) K201789

Substantially Equivalent

Energy Delivery Solutions

FDA 510(k) clearance K201789 for CT-STOR, Substantially Equivalent on 2021-09-20. Applicant: Energy Delivery Solutions. Device class: 2.

Clearance details

Applicant: Energy Delivery Solutions
Product code: Code NDS
Device class: Class 2
Regulation: 21 CFR 876.5885
Advisory panel: Gastroenterology, Urology
Date received: 2020-06-30
Decision date: 2021-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffersonville, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.