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Sponsors
· Wellspect AB
Wellspect AB
Mölndal, SE · 3 510(k) clearances
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Total clearances
3
2025-09-26 → 2026-07-17
Last 12 months
3
Product codes
1
Most recent
2026-07-17
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by quarter
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Product codes
worked
Code
Device name
Class
Specialty
Clearances
Most recent
EZD
Catheter, Straight
Class II
Gastroenterology, Urology
3
2026-07-17
Filings
All 510(k) clearances
(3)
Date
K-number
Device
Code
Class
Specialty
2026-07-17
K261658
LoFric Origo Pro Coudé
EZD
Class II
Gastroenterology, Urology
2026-04-24
K260999
LoFric Elle Pro
EZD
Class II
Gastroenterology, Urology
2025-09-26
K250659
LoFric Origo
EZD
Class II
Gastroenterology, Urology