FDA.report

510(k) K250275

Device
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
Applicant
Baylis Medical Technologies, Inc.
510(k) number
K250275
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-28
Date received
2025-01-31
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Barb Boyce
Address
2645 Matheson Blvd. E. Mississauga CA L4W5S4 L4W5S4

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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