Tech-Image Video Endoscope System— 510(k) K260414

Name: FDA 510(k) clearance K260414
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Tech-Image CO., LTD.

FDA 510(k) clearance K260414 for Tech-Image Video Endoscope System, Substantially Equivalent on 2026-06-10. Applicant: Tech-Image CO., LTD.. Device class: 2.

Summary

Tech-Image's Tech-Image Video Endoscope System is filed under GCJ, laparoscopes for general and plastic surgery. The record gives no model numbers or components.

Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k); the record lists Gastroenterology and Urology as the classification panel.

Tech-Image filed from Taipei City, Taiwan. The decision came 121 calendar days after FDA received it (February 9 to June 10, 2026).

Clearance details

Applicant: Tech-Image CO., LTD.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-02-09
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.