TL-10 Laparoscopic Scope Cleaner— 510(k) K260089
Substantially EquivalentScopix , 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 meant for cleaning a laparoscope's lens during surgery. The record doesn't describe how it works. It's filed under GCJ, laparoscopes for general and plastic surgery, which also covers accessories like this.
Class II, 21 CFR 876.1500. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
Scopix filed from Amikam, Israel. Review took 86 days (January 12 to April 8, 2026).
Clearance details
- Applicant
- Scopix , Ltd.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amikam, IL
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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, through . 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.