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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 a medical device manufactured by Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-28 under approval 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. It is manufactured by Baylis Medical Technologies, Inc.. The 510(k) number is K250275.

When was PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch approved by the FDA?

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

What company makes PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch?

PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch is manufactured by Baylis Medical Technologies, Inc..

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.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

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Official Source

View on FDA Database →

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

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