FDA 510(k) clearance · back to tracker

FloNavi Endoscopic Fluorescence Imaging System

Guangdong Optomedic Technologies, Inc. cleared K221861 on 2023-02-18, decision: substantially equivalent

K-number

K221861

Sponsor

Guangdong Optomedic Technologies, Inc.

Device

FloNavi Endoscopic Fluorescence Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-02-18

Product code

GCJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K221861on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.