Disposable Plastic Syringe & Needle

by Marshall Davis, Inc.

510(k) K820062

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K820062↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK820062	Date1 Apr 1982Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K820062
FDA Product Code: FMF

Device Class: Class II
Regulation: 21 CFR Part 880.5860
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Syringe, Piston (Medical Specialty: General Hospital), designed for single-use administration or withdrawal of fluids in clinical settings. Constructed from disposable plastic, it combines a syringe barrel with an integrated needle for precise dosing and minimal contamination risk.

Supplied sterile and intended for one-time use, the device adheres to FDA 510(k) clearance (K820062, FMF) under regulation 880.5860. No third-party review was conducted, and it is classified as a Class II medical device under traditional clearance. Storage requires protection from physical damage and contamination prior to use.