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.
Other records listing Guangdong Optomedic Technologies, Inc. as applicant
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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.