Cleared Traditional

K180417 - Self-destruction Safety Syringes for Single Use (FDA 510(k) Clearance)

Also includes:
Sterile Hypodermic Syringes for Single Use Sterile Hypodermic Needles for Single Use Sterile Safety Hypodermic Needles for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · General Hospital
Aug 2018
Decision
175d
Days
Class 2
Risk

K180417 is an FDA 510(k) clearance for the Self-destruction Safety Syringes for Single Use. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).

Submitted by Berpu Medical Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on August 9, 2018, 175 days after receiving the submission on February 15, 2018.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K180417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2018
Decision Date August 09, 2018
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG - Syringe, Antistick
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5860