Name: Predicase
Price: 199 USD

K-number	K250275
Device name	PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch
Applicant	Baylis Medical Technologies, Inc.
Product code	GEI
Device class	Class II
Decision date	Oct 28, 2025
Decision	Substantially Equivalent
Regulation	878.4400

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch

Everything you need for a 510(k) submission. Nothing you don't.

PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch