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Microplex Coil System-Cosmos (100933cssr-V +3 more) - 101141cssr-V

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093919

by Microvention Inc.

Identifiers

510(k) Number
K093919 FDA 510(k)
FDA Product Code
HCG FDA 510(k)
Models / Variants
100933cssr-V FDA 510(k)
101036cssr-V FDA 510(k)
101141cssr-V FDA 510(k)
101245cssr-V FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5950 FDA 510(k)
Regulation Number
882.5950 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Microplex Coil System-Cosmos (100933cssr-V +3 more) - 101141cssr-V by Microvention Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microvention Inc.
FDA Applicant
MicroVention, Inc.

Sources (1)

  • FDA 510(k) K093919 24 fields · synced Jun 18, 2026