Atlas FDA

FEZ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Catheter And Tube, Suprapubic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5090
Medical specialty
Gastroenterology, Urology
Flags
Implant
Adverse events (MAUDE)
1992: 1 · 1994: 1 · 2000: 1 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CATHETER, SAMPLING, CONDUIT (K771066)Mentor Corp.1977-07-11

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Every clearance here is in the API, with alerts when new ones post.