E-Brik Visualization Assistant— 510(k) K221293

Name: FDA 510(k) clearance K221293
Creator: U.S. Food and Drug Administration
Published: 2022-07-07

Substantially Equivalent

Jdi Surgical, Inc.

FDA 510(k) clearance K221293 for E-Brik Visualization Assistant, Substantially Equivalent on 2022-07-07. Applicant: Jdi Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Jdi Surgical, Inc.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-05-04
Decision date: 2022-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highlands Ranch, CO, US

Download summary PDF View on FDA.gov ↗

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