FDA 510(k)

Single-use Flexible Ureteroscope

K-번호: K250785 · 2025-05-06

신청자Hunan Vathin Medical Instrument Co., Ltd.

결정일2025-05-06

제품 코드FGB

자문 위원회GU

결정Substantially Equivalent

기기 요약

Single-use Flexible Ureteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-05-06 under 510(k) number K250785. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Single-use Flexible Ureteroscope?

Single-use Flexible Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-05-06. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K250785.

When did Single-use Flexible Ureteroscope receive FDA 510(k) clearance?

Single-use Flexible Ureteroscope received FDA 510(k) clearance on 2025-05-06, under 510(k) number K250785.

Who is the listed applicant for Single-use Flexible Ureteroscope?

The FDA 510(k) record lists Hunan Vathin Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Flexible Ureteroscope?

The FDA product code for Single-use Flexible Ureteroscope is FGB.

Hunan Vathin Medical Instrument Co., Ltd.를 신청인으로 등재한 기타 기록

K261637Single-use Flexible Bronchoscope K250232Vathin® Video Bronchoscope System K251599Single-use Ureteral Access Sheath K243117Digital Video Processor K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

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