IVALON EMBOLIZATION PARTICLES— 510(k) K913556

Name: FDA 510(k) clearance K913556
Creator: U.S. Food and Drug Administration
Published: 1994-04-13

Substantially Equivalent

Ivalon

FDA 510(k) clearance K913556 for IVALON EMBOLIZATION PARTICLES, Substantially Equivalent on 1994-04-13. Applicant: Ivalon. Device class: 2.

Clearance details

Applicant: Ivalon
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 1991-08-09
Decision date: 1994-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K946016 — IVALON OPHTHALMIC SPONGE1995-03-22
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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.