TL-10 Laparoscopic Scope Cleaner— 510(k) K260089

Name: FDA 510(k) clearance K260089
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Substantially Equivalent

Scopix , Ltd.

FDA 510(k) clearance K260089 for TL-10 Laparoscopic Scope Cleaner, Substantially Equivalent on 2026-04-08. Applicant: Scopix , Ltd.. Device class: 2.

Summary

The TL-10 Laparoscopic Scope Cleaner is filed under GCJ, laparoscopes for general and plastic surgery. Going by the name, it cleans laparoscopic scopes, but the record doesn't describe how it works.

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

Scopix filed from Amikam, Israel. Review took 86 days (January 12 to April 8, 2026).

Clearance details

Applicant: Scopix , Ltd.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-01-12
Decision date: 2026-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amikam, IL

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.