FDA 510(k) clearance · back to tracker
Polaris RF Ablation System
Baylis Medical Company, Inc. cleared K181864 on 2019-01-02, decision: substantially equivalent
K-number
K181864
Sponsor
Baylis Medical Company, Inc.
Device
Polaris RF Ablation System
Class
Class II
Decision
Substantially Equivalent
Decision date
2019-01-02
Product code
GXD
Advisory committee
Neurology
Medical specialty
Neurology
Regulation number
882.4400
Official FDA record
Open K181864on 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 K181864 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.