Question 1

Who is the manufacturer of PISTON SYRINGE?

Accepted Answer

Sherwood Medical Co. filed the 510(k) submission for PISTON SYRINGE (K811065).

Question 2

What is the FDA product code for PISTON SYRINGE?

Accepted Answer

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

Question 3

When was PISTON SYRINGE cleared by the FDA?

Accepted Answer

May 5, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for PISTON SYRINGE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PISTON SYRINGE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K811065
Device Name	PISTON SYRINGE
Applicant	Sherwood Medical Co.
Product Code	FMF · General Hospital
Decision Date	May 5, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2

PISTON SYRINGE

Device Facts

Regulatory Classification

Identification