Cleared Special

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT

K133425 · Engineered Medical Solutions Co., LLC · General & Plastic Surgery
Dec 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K133425 is an FDA 510(k) clearance for the SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT, a Lamp, Surgical (Class II — Special Controls, product code FTD), submitted by Engineered Medical Solutions Co., LLC (Phillipsburg, US). The FDA issued a Cleared decision on December 5, 2013, 27 days after receiving the submission on November 8, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K133425 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2013
Decision Date December 05, 2013
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTD — Lamp, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580