510(k) Report

Devices descending from K964561

3 later devices reach Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR… through their predicates, nearest generation first.

Generation	Number	Device	Applicant	Decided	Own descendants	Recalls
+1	K991323	Smith & Nephew Subcutaneous Illuminator	Smith & Nephew, Inc.	1999	2	—
+2	K032387	Trivex System	Smith & Nephew, Inc.	2003	1	1
+3	K212894	PhasTIPP	LeMaitre Vascular, Inc.	2022	0	—