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Safesharpe Disposal System

by Life Medical Technologies, Inc.

510(k) K925056

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 NumberK925056 Date21 Apr 1995ClearedStatusActive

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  • Withdrawn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)

Full name
Safesharpe (Tm) Disposal System
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, 1 Oct 2026

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

The Safesharpe Disposal System is a sharps injury prevention device designed for the safe disposal of used needles and other sharp medical instruments. It falls under the category of sharps disposal containers with integrated safety features, intended to minimize the risk of accidental needle sticks during disposal.

This system is supplied as a single-use device and is regulated under FDA 510(k) clearance (K925056) with a classification under product code FMI. It is intended for use in general hospital settings, adhering to standard infection control and safety protocols for sharps disposal. The device is not MRI-safe, and no additional storage or handling specifications beyond standard sharps disposal guidelines are noted.

Questions

AI-generated answers, 1 Oct 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 Safesharpe™ Disposal System used for?

    The Safesharpe™ Disposal System is designed specifically to minimize the risk of accidental needle sticks and sharps injuries during the disposal of used needles and other sharp medical instruments. It integrates safety features into a sharps disposal container, ensuring compliance with infection control protocols in general hospital settings.

  • Is the Safesharpe™ Disposal System reusable or single-use?

    The Safesharpe™ Disposal System is supplied as a single-use device. This design choice ensures that each container is dedicated to one disposal cycle, reducing the risk of contamination or cross-infection between uses.

  • Does the Safesharpe™ Disposal System require any special storage or handling beyond standard sharps disposal guidelines?

    No additional storage or handling specifications are noted beyond standard sharps disposal guidelines. The device is intended for general hospital use and does not require special conditions beyond those already established for sharps disposal.

  • Is the Safesharpe™ Disposal System MRI-safe?

    The Safesharpe™ Disposal System is explicitly noted as not MRI-safe. This means it should not be used or stored in areas where MRI scans are conducted, as the materials may interfere with imaging or pose risks during the procedure.

  • What regulatory clearance does the Safesharpe™ Disposal System hold?

    The Safesharpe™ Disposal System holds FDA 510(k) clearance under the classification of substantially equivalent to predicate devices, with clearance number K925056. This clearance is specific to its use in general hospital settings for sharps injury prevention.