K242513
- 510(k) number
- K242513
- Device name
- FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
- Applicant
- Guangdong Optomedic Technologies, Inc. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-10-23
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242513
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.