Cleared Traditional

IDSS SLC

K133413 · Black Diamond Video · General & Plastic Surgery
Jan 2014
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K133413 is an FDA 510(k) clearance for the IDSS SLC, a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by Black Diamond Video (Richmond, US). The FDA issued a Cleared decision on January 7, 2014, 61 days after receiving the submission on November 7, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K133413 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2013
Decision Date January 07, 2014
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTA — Light, Surgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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