FDA 510(k)

Nuvis® 무선 HD 캠에라 시스템 (Nuvis-2K)

K-번호: K242606 · 2025-11-20

결정일2025-11-20

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Nuvis® Wireless HD Camera System (Nuvis-2K) is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Endoscopy, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K242606. 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 Nuvis® Wireless HD Camera System (Nuvis-2K)?

Nuvis® Wireless HD Camera System (Nuvis-2K) is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Integrated Endoscopy, Inc.. The 510(k) number is K242606.

When did Nuvis® Wireless HD Camera System (Nuvis-2K) receive FDA 510(k) clearance?

Nuvis® Wireless HD Camera System (Nuvis-2K) received FDA 510(k) clearance on 2025-11-20, under 510(k) number K242606.

Who is the listed applicant for Nuvis® Wireless HD Camera System (Nuvis-2K)?

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

What is the FDA product code for Nuvis® Wireless HD Camera System (Nuvis-2K)?

The FDA product code for Nuvis® Wireless HD Camera System (Nuvis-2K) is GCJ.

Integrated Endoscopy, Inc.를 신청인으로 등재한 기타 기록

K191594nuvis 배터리 관절내시경

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