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Modification To: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series)

by Safety Syringes, Inc.

510(k) K060743

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 NumberK060743 Date28 Apr 2006ClearedStatusActive

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  • Withdrawn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, 24 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, antistick, classified as a Class II medical device under FDA regulation 880.5860. It is a modification to the tamper-evident Ultrasafe passive delivery system, designed as an accessory for use with prefilled ISO standard glass syringes to aid in the protection of healthcare professionals.

The device is supplied as a single-use accessory and is indicated for use in general hospital settings. It received FDA 510(k) clearance (K060743) on April 28, 2006, as substantially equivalent to a predicate device. The product code is MEG, and it is manufactured by Safety Syringes, Inc. in Carlsbad, California.

Other devices from Safety Syringes, Inc.

See all devices from Safety Syringes, Inc. →

Questions

AI-generated answers, 24 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 Modification to Tamper Evident Ultrasafe Passive Delivery System X-Series used for?

    It is an accessory designed to aid in the protection of healthcare professionals when used with prefilled ISO standard glass syringes in general hospital settings, as indicated in the device description.

  • Is the Modification to Tamper Evident Ultrasafe Passive Delivery System X-Series supplied sterile and for single-use only?

    The device is supplied as a single-use accessory, meaning it is intended for one-time use and should not be reused, based on its classification and intended use as an accessory for prefilled syringes.

  • What regulatory pathway was used for the Modification to Tamper Evident Ultrasafe Passive Delivery System X-Series?

    The device received FDA 510(k) clearance (K060743) on April 28, 2006, as substantially equivalent to a predicate device, which is the regulatory pathway indicated in the authorizations and decision description.