PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch— 510(k) K250275

Substantially Equivalent

Baylis Medical Technologies, Inc.

FDA 510(k) clearance K250275 for PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch, Substantially Equivalent on 2025-10-28. Applicant: Baylis Medical Technologies, Inc..

Clearance details

Applicant: Baylis Medical Technologies, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-01-31
Decision date: 2025-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.