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FDA 510(k)

亚历克斯照明伤口保护器-拉钩，柔性，特小（cl312）；亚历克斯照明伤口保护器-拉钩，柔性，小（cl301）；亚历克斯照明伤口保护器-拉钩，柔性，中（cl302）；亚历克斯照明伤口保护器-拉钩，柔性，大（cl303）；亚历克斯照明伤口保护器-拉钩，刚性，小（cl401）；亚历克斯照明伤口保护器-拉钩，刚性，中（cl402）；亚历克斯照明伤口保护器-拉钩，刚性，大（cl403）

K-번호: K260982 · 2026-04-24

신청자Applied Medical Resources Corporation
결정일2026-04-24
제품 코드KGW
자문 위원회SU
결정Substantially Equivalent

기기 요약

Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260982. The device is classified under product code KGW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)?

Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K260982.

When did Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) receive FDA 510(k) clearance?

Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260982.

Who is the listed applicant for Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)?

The FDA product code for Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) is KGW.

관련 임상시험

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

NCT07608549플래시 파일 1차 피로트 단계 안전 연구NOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING

Applied Medical Resources Corporation를 신청인으로 등재한 기타 기록

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K253531亚历克斯®照明伤口保护器-拉钩，刚性，中（CL402）；亚历克斯®照明伤口保护器-拉钩，柔性，中（CL302）K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)K232880인지이 리프스톱 리데플로이어블 리트리벌 시스템K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)K220969GelPOINT V-Path 자궁 경부 접근 시스템K211043亚历克斯包含提取系统

12개 장치 모두 보기 →

관련 기기 (코드: KGW)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K253531亚历克斯®照明伤口保护器-拉钩，刚性，中（CL402）；亚历克斯®照明伤口保护器-拉钩，柔性，中（CL302）Applied Medical Resources Corporation

공식 출처

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

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