Cleared Traditional

E-Brik Visualization Assistant

K221293 · Jdi Surgical, Inc. · General & Plastic Surgery

Jul 2022

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K221293 is an FDA 510(k) clearance for the E-Brik Visualization Assistant, a Anti Fog Solution And Accessories, Endoscopy (Class II — Special Controls, product code OCT), submitted by Jdi Surgical, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on July 7, 2022, 64 days after receiving the submission on May 4, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K221293 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2022
Decision Date	July 07, 2022
Days to Decision	64 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OCT — Anti Fog Solution And Accessories, Endoscopy
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.