Cleared Traditional

KOGENT SPETZLER LIGHTED SUCTION TUBES

K141781 · Katalyst Surgical, LLC · General & Plastic Surgery
Apr 2015
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K141781 is an FDA 510(k) clearance for the KOGENT SPETZLER LIGHTED SUCTION TUBES, a Illuminator, Fiberoptic, Surgical Field (Class II — Special Controls, product code HBI), submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on April 9, 2015, 281 days after receiving the submission on July 2, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K141781 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2014
Decision Date April 09, 2015
Days to Decision 281 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code HBI — Illuminator, Fiberoptic, Surgical Field
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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