FDA 510(k)

Easydrip 클래식 펜 나침반; Easydrip 플러스 펜 나침반; Easydrip 클래식 프로 펜 나침반; Easydrip 플러스 프로 펜 나침반

K-번호: K252908 · 2026-03-25

결정일2026-03-25

제품 코드FMI

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Sandstone Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252908. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle?

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Sandstone Medical (Suzhou), Inc.. The 510(k) number is K252908.

When did Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle receive FDA 510(k) clearance?

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252908.

Who is the listed applicant for Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle?

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

What is the FDA product code for Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle?

The FDA product code for Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle is FMI.

Sandstone Medical (Suzhou), Inc.를 신청인으로 등재한 기타 기록

K210864안전 펜 주사針 K193422Easydrip 펜 나침반, Easydrip Plus 펜 나침반

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