MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR— 510(k) K031578

Name: FDA 510(k) clearance K031578
Creator: U.S. Food and Drug Administration
Published: 2003-08-01

Substantially Equivalent

Micrus Corp.

FDA 510(k) clearance K031578 for MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR, Substantially Equivalent on 2003-08-01. Applicant: Micrus Corp.. Device class: 2.

Clearance details

Applicant: Micrus Corp.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2003-05-20
Decision date: 2003-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Micrus Corp.

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K032624 — MICRUS MICROCATHETER2003-09-10
K022420 — MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR012002-10-22
K002056 — MICRUS MICROCOIL DELIVERY SYSTEM, MDS032001-01-11

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.