Cleared Special

K133425 - SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT

K133425 is an FDA 510(k) clearance for SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, manufactured by Engineered Medical Solutions Co., LLC. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Special 510(k) pathway after a 27-day FDA review.

K133425 · Engineered Medical Solutions Co., LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
27d
Days
Class 2
Risk

K133425 is an FDA 510(k) clearance for the SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGI.... Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Engineered Medical Solutions Co., LLC (Phillipsburg, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133425

510(k) Number K133425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

FTD Device Classification - Class 2, Special Controls

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTD Lamp, Surgical

All 25
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K133425.
VOLISTA 400
K130513 · Maquet S.A.S. · May 2013
POLARIS 100/200
K123776 · Drager Medical GmbH · Mar 2013
ATRICURE DISSECTOR
K111020 · AtriCure, Inc. · Jun 2011
HM-LAMP II
K100234 · Hillusa, Inc. · Jul 2010
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · Engineered Medical Solutions Co., LLC · Jun 2007
K133425 · SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
Download PDF FDA Summary Engineered Medical So…