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Pro.Duct Health Micro-Stylet, Model STY01

by Pro. Duct Health, Inc.

510(k) K001098

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001098 Date18 May 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Pro.Duct Health Micro-Stylet, Model STY01 is a hypodermic single lumen needle device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It consists of a metal tube sharpened at one end and joined to a female connector at the other end.

The device is supplied by Pro.Duct Health, Inc. and has FDA 510(k) clearance with number K001098. It is regulated under product code FMI and was cleared on May 18, 2000. The device is not specified as single-use or reusable, and no MRI safety information is provided.

Other devices from Pro. Duct Health, Inc.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Pro.Duct Health Micro-Stylet STY01 used for?

    The Micro-Stylet STY01 is a hypodermic single lumen needle device designed to inject fluids into or withdraw fluids from parts of the body below the surface of the skin. It consists of a metal tube sharpened at one end and connected to a female connector at the other end.

  • Is the Micro-Stylet STY01 single-use or reusable?

    The device is not specified as single-use or reusable in the available information. Users should refer to the manufacturer's instructions for specific guidance on reuse or disposal protocols.

  • What regulatory approvals does the Micro-Stylet STY01 have?

    The Pro.Duct Health Micro-Stylet STY01 has FDA 510(k) clearance with number K001098. It was cleared on May 18, 2000, and is regulated under product code FMI. The device was determined to be substantially equivalent through the traditional clearance pathway.

  • How is the Micro-Stylet STY01 supplied?

    The device is supplied by Pro.Duct Health, Inc., located at 1360 Willow Rd., Suite 201, Menlo Park, CA 94025. The specific packaging and quantities per package are not detailed in the available information.