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FDA 510(k)

3D Laparoscope

K-Number: K252697 · 2025-10-29

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2025-10-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3D Laparoscope is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K252697. 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 3D Laparoscope?

3D Laparoscope is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K252697.

When did 3D Laparoscope receive FDA 510(k) clearance?

3D Laparoscope received FDA 510(k) clearance on 2025-10-29, under 510(k) number K252697.

Who is the listed applicant for 3D Laparoscope?

The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D Laparoscope?

The FDA product code for 3D Laparoscope is GCJ.

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Other records listing Guangdong Optomedic Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252318Insufflator (OPTO-IFL1000)K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)K241530Stellar Imaging SystemK231342Insufflator (OPTO-IFL1000)K230407FloNavi Open Field Fluorescence Imaging SystemK231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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.

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