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FDA 510(k)

TL-10 Laparoscopic Scope Cleaner

K-Number: K260089 · 2026-04-08

ApplicantScopix , Ltd.
Decision Date2026-04-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TL-10 Laparoscopic Scope Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Scopix , Ltd.. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K260089. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TL-10 Laparoscopic Scope Cleaner?

TL-10 Laparoscopic Scope Cleaner is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Scopix , Ltd.. The 510(k) number is K260089.

When did TL-10 Laparoscopic Scope Cleaner receive FDA 510(k) clearance?

TL-10 Laparoscopic Scope Cleaner received FDA 510(k) clearance on 2026-04-08, under 510(k) number K260089.

Who is the listed applicant for TL-10 Laparoscopic Scope Cleaner?

The FDA 510(k) record lists Scopix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TL-10 Laparoscopic Scope Cleaner?

The FDA product code for TL-10 Laparoscopic Scope Cleaner is GCJ.

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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