KOB

Catheter, Suprapubic (And Accessories)

Product code: KOB
Device name: Catheter, Suprapubic (And Accessories)
Device class: Class 2
21 CFR: 21 CFR 876.5090
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 32 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-11-01.

Number	Decision date	Applicant	Device name	Summary
K240514	2024-11-01	Applied Medical Technology, Inc.	AMT Low-Profile Suprapubic Catheter & Drainage Set	PDF

1 summaries are archived here for direct download.

Official FDA classification page: KOB

Classification and pathway per current FDA publications. Data from openFDA (CC0).