FDA 510(k) clearance · back to tracker

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

Guangdong Optomedic Technologies, Inc. cleared K242513 on 2024-10-23, decision: substantially equivalent

K-number

K242513

Sponsor

Guangdong Optomedic Technologies, Inc.

Device

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-10-23

Product code

GCJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K242513on 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.