510(k) K200874

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End by Innovasis, Inc. — Product Code FST

K200874 is an FDA 510(k) premarket notification submitted by Innovasis, Inc. for the device "TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End". The FDA issued a decision of Substantially Equivalent on June 30, 2020. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Innovasis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2020
Date Received
April 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Fiberoptic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type