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U.S. Department of Health and Human Services

Product Classification

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Device endoscope, accessories, narrow band spectrum
Regulation Description Endoscope and accessories.
Definition Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Physical State The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display
Technical Method Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optical filters or using light sources with inherently limited spectra such as lasers
Target Area Limited to endoscopic systems for observation of the gastro-urological tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNWB
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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