FDA 510(k)

Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)

K-Nummer: K252745 · 2025-12-12

AntragstellerMicro-Energy Medical Technology Co., Ltd.

Entscheidungsdatum2025-12-12

ProduktcodeGEX

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Energy Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K252745. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)?

Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Micro-Energy Medical Technology Co., Ltd.. The 510(k) number is K252745.

When did Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) receive FDA 510(k) clearance?

Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252745.

Who is the listed applicant for Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)?

The FDA 510(k) record lists Micro-Energy Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)?

The FDA product code for Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) is GEX. This falls under the Gastroenterology category.

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Offizielle Quelle

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