MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01— 510(k) K022420

Name: FDA 510(k) clearance K022420
Creator: U.S. Food and Drug Administration
Published: 2002-10-22

Substantially Equivalent

Micrus Corp.

FDA 510(k) clearance K022420 for MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01, Substantially Equivalent on 2002-10-22. 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: 2002-07-24
Decision date: 2002-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCG

view all

K262419 — MICRUSFRAME (19+ models)2026-08-14
K261772 — Target Xtra Detachable Coil2026-06-24
K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
K252694 — Target Detachable Coil2025-12-11

More clearances from Micrus Corp.

view all

K033813 — MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE2004-02-04
K032872 — MICRUS MICROCOIL SYSTEM2003-11-28
K032624 — MICRUS MICROCATHETER2003-09-10
K031578 — MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR2003-08-01
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.