Who is the manufacturer of TERUMO U-100 INSULIN SYRING?

Terumo Medical Corp. submitted the Special clearance for TERUMO U-100 INSULIN SYRING (K001474).

What is the FDA product code for TERUMO U-100 INSULIN SYRING?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for TERUMO U-100 INSULIN SYRING?

510(k) clearance (submission type: Special).

TERUMO U-100 INSULIN SYRING

K001474 · Terumo Medical Corp. · FMF · Jun 9, 2000 · General Hospital

Device Facts

Record ID	K001474
Device Name	TERUMO U-100 INSULIN SYRING
Applicant	Terumo Medical Corp.
Product Code	FMF · General Hospital
Decision Date	Jun 9, 2000
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5860
Device Class	Class 2

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.