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FDA 510(k)

PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch

K-Number: K250275 · 2025-10-28

ApplicantBaylis Medical Technologies, Inc.
Decision Date2025-10-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-28 under 510(k) number K250275. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch?

PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Baylis Medical Technologies, Inc.. The 510(k) number is K250275.

When did PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch receive FDA 510(k) clearance?

PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch received FDA 510(k) clearance on 2025-10-28, under 510(k) number K250275.

Who is the listed applicant for PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch?

The FDA 510(k) record lists Baylis Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch?

The FDA product code for PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch is GEI.

Other records listing Baylis Medical Technologies, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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