FDA 510(k)

HOTWIRE™ System RF Generator and Footswitch (optional accessory)

K-번호: K252083 · 2025-08-12

결정일2025-08-12

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

HOTWIRE™ System RF Generator and Footswitch (optional accessory) is the device name listed in this FDA 510(k) record. The listed applicant is Atraverse Medical, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K252083. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

HOTWIRE™ System RF Generator and Footswitch (optional accessory) is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Atraverse Medical, Inc.. The 510(k) number is K252083.

When did HOTWIRE™ System RF Generator and Footswitch (optional accessory) receive FDA 510(k) clearance?

HOTWIRE™ System RF Generator and Footswitch (optional accessory) received FDA 510(k) clearance on 2025-08-12, under 510(k) number K252083.

Who is the listed applicant for HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

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

What is the FDA product code for HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

The FDA product code for HOTWIRE™ System RF Generator and Footswitch (optional accessory) is GEI.

Atraverse Medical, Inc.를 신청인으로 등재한 기타 기록

K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

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