FloNavi Endoscopic Fluorescence Imaging System
K-Number: K221861 · 2023-02-18
Decision Date2023-02-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FloNavi Endoscopic Fluorescence Imaging System is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-18 under approval number K221861. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FloNavi Endoscopic Fluorescence Imaging System?
FloNavi Endoscopic Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2023-02-18. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K221861.
When was FloNavi Endoscopic Fluorescence Imaging System approved by the FDA?
FloNavi Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2023-02-18, under approval number K221861.
What company makes FloNavi Endoscopic Fluorescence Imaging System?
FloNavi Endoscopic Fluorescence Imaging System is manufactured by Guangdong Optomedic Technologies, Inc..
What is the FDA product code for FloNavi Endoscopic Fluorescence Imaging System?
The FDA product code for FloNavi Endoscopic Fluorescence Imaging System is GCJ.
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Other Devices by Guangdong Optomedic Technologies, Inc.
K231342Insufflator (OPTO-IFL1000)
K230407FloNavi Open Field Fluorescence Imaging System
K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
K241530Stellar Imaging System
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.