Cleared Traditional

SaviSafe Safety Device

K230287 · Suzhou Savicred Biotechnology Co., Ltd. · General Hospital

Nov 2023

Decision

292d

Days

Class 2

Risk

About This 510(k) Submission

K230287 is an FDA 510(k) clearance for the SaviSafe Safety Device, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Suzhou Savicred Biotechnology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 21, 2023, 292 days after receiving the submission on February 2, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K230287 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2023
Decision Date	November 21, 2023
Days to Decision	292 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF