FDA 510(k) clearance · back to tracker
VIA360 Surgical System
New World Medical, Inc. cleared K243503 on 2025-02-14, decision: substantially equivalent
K-number
K243503
Sponsor
New World Medical, Inc.
Device
VIA360 Surgical System
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-02-14
Product code
MRH
Advisory committee
General Hospital
Medical specialty
General Hospital
Regulation number
880.5725
Official FDA record
Open K243503on 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.
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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.