Name: Predicase
Price: 199 USD

K-number	K252697
Device name	3D Laparoscope
Applicant	Guangdong Optomedic Technologies, Inc.
Product code	GCJ
Device class	Class II
Decision date	Oct 29, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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3D Laparoscope

Everything you need for a 510(k) submission. Nothing you don't.