Cleared Traditional

K121724 - ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2

K121724 is an FDA 510(k) clearance for ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K121724 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Sep 2012
Decision
100d
Days
Class 2
Risk

K121724 is an FDA 510(k) clearance for the ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K121724

510(k) Number K121724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2012
Decision Date September 20, 2012
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 131d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCW Light Source, Fiberoptic, Routine

All 20
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K121724.
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K091968 · KARL STORZ Endoscopy-America, Inc. · Sep 2009
STRYKER LED LIGHTSOURCE
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COLDLIGHTSOURCE PL3000
K993300 · Fiber Imaging Technologies, Inc. · Nov 1999