FDA 510(k)

TL-10 내시경 스코프 청소기

K-번호: K260089 · 2026-04-08

결정일2026-04-08

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

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TL-10 내시경 스코프 청소기

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GCJ)

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