FDA 510(k) clearance · back to tracker
Numen Helia Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd. cleared K260351 on 2026-05-20, decision: substantially equivalent
K-number
K260351
Sponsor
MicroPort NeuroTech (Shanghai) Co., Ltd.
Device
Numen Helia Coil Embolization System; NumenFR Detachment System
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-05-20
Product code
HCG
Advisory committee
Neurology
Medical specialty
Neurology
Regulation number
882.5950
Official FDA record
Open K260351on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K260351 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.