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Prosafe Safety Syringe

by Hou-Se Medical, Inc.

510(k) K012726

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 NumberK012726 Date18 Oct 2001ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 28 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 Prosafe Safety Syringe is a syringe designed to gain access to a patient's vascular or intramuscular system for short term fluid sampling or infusion. It consists of a syringe assembly and a needle assembly, and has a built-in safety feature to reduce the risk of accidental needlestick injury.

The Prosafe Safety Syringe is supplied as a single-use device, and is classified under the regulation number 880.5860, with a product code of MEG. It has been cleared by the FDA under the 510(k) premarket notification, with the clearance number K012726.

Questions

AI-generated answers, 28 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 Prosafe Safety Syringe used for?

    The Prosafe Safety Syringe is used to gain access to a patient's vascular or intramuscular system for short term fluid sampling or infusion.

  • Is the Prosafe Safety Syringe a single-use device?

    Yes, the Prosafe Safety Syringe is supplied as a single-use device to ensure patient safety and prevent cross-contamination.

  • What regulatory clearance has the Prosafe Safety Syringe received?

    The Prosafe Safety Syringe has been cleared by the FDA under the 510(k) premarket notification with clearance number K012726.