Endoscope, Accessories, Narrow Band Spectrum

NWB · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code: NWB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1500
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 31

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown