FDA 510(k)

PrecisePath® Radiofrequency Puncture Generator and PrecisePath® Footswitch

K号: K250275 · 2025-10-28

决定日期2025-10-28

产品代码GEI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Baylis Medical Technologies, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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