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..
Summary
The TL-10 Laparoscopic Scope Cleaner is a disposable cleaning device for laparoscopic camera tips — used intraoperatively to wipe the scope without removing it from the abdomen. Product code GCJ covers laparoscopes and related instruments; scope-cleaning accessories are a niche within it.
Gastroenterology, Urology panel, Traditional 510(k). GCJ scope cleaners are cleared on straightforward substantial-equivalence arguments against existing wipe or brush products — it's mechanically simple with a small but active predicate set.
Scopix, Ltd. files from Amikam, Israel. Three-month review clock. A short clock on a specialty accessory device with a clean predicate lineage is typical.
Clearance details
- Applicant
- Scopix , Ltd.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amikam, IL
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.