ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT— 510(k) K864225

Name: FDA 510(k) clearance K864225
Creator: U.S. Food and Drug Administration
Published: 1987-01-30

Substantially Equivalent

Angiomed U.S., Inc.

FDA 510(k) clearance K864225 for ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT, Substantially Equivalent on 1987-01-30. Applicant: Angiomed U.S., Inc.. Device class: 2.

Clearance details

Applicant: Angiomed U.S., Inc.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1986-10-28
Decision date: 1987-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS1986-10-24
K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE1986-09-29
K863446 — ANGIOMED HIGH PRESSURE CONNECTORS1986-09-23

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.