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Sharghp Insulin Syringes

by Shargh Pharmaceutical Co., Inc.

510(k) K895980

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 NumberK895980 Date7 Sep 1990ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 23 Sep 2026

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

Sharghp Insulin Syringes are medical devices designed for the administration of insulin to patients with diabetes. These syringes are manufactured by Shargh Pharmaceutical Co., Inc. and are intended for use in clinical settings.

The device is supplied as a single-use product and is regulated under FDA 510K clearance with product code FMF. It is available in various sizes and should be stored according to manufacturer instructions. The device received FDA clearance on September 7, 1990, and is classified under the General Hospital advisory committee.

Other devices from Shargh Pharmaceutical Co., Inc.

Questions

AI-generated answers, 23 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 are Sharghp Insulin Syringes used for?

    Sharghp Insulin Syringes are medical devices specifically designed for the administration of insulin to patients with diabetes in clinical settings.

  • Are these syringes single-use or reusable?

    Sharghp Insulin Syringes are supplied as single-use products, meaning they should be discarded after one use to ensure patient safety and prevent contamination.

  • What sizes and models are available for these insulin syringes?

    The device is available in various sizes to accommodate different insulin dosage requirements, though specific size options are not detailed in the provided information.

  • How should Sharghp Insulin Syringes be stored?

    These syringes should be stored according to the manufacturer's instructions to maintain their integrity and ensure proper functionality when used.

  • What is the regulatory status of these syringes?

    Sharghp Insulin Syringes are regulated under FDA 510K clearance with product code FMF, having received clearance on September 7, 1990.