Cleared Traditional

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End

K200874 · Innovasis, Inc. · General & Plastic Surgery
Jun 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K200874 is an FDA 510(k) clearance for the TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 30, 2020, 90 days after receiving the submission on April 1, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K200874 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2020
Decision Date June 30, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FST — Light, Surgical, Fiberoptic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580