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Vial Adapter 15mm

by Medimop Medical Project, Ltd.

510(k) K171796

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 · Special NumberK171796 Date12 Oct 2017ClearedStatusActive

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  • Withdrawn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
LHI
FDA applicant
Medimop Medical Project , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Vial Adapter 15mm is a single-piece molded polycarbonate device designed to facilitate the reconstitution and transfer of drugs contained in vials. It functions as a dispensing pin to enable the safe and efficient movement of medication.

This device is intended for use in a general hospital setting. It has received FDA 510(k) clearance under the special pathway.

Other devices from Medimop Medical Projects, Ltd.

See all devices from Medimop Medical Projects, Ltd. →

Questions

AI-generated answers, 6 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 primary function of the Vial Adapter 15mm?

    The Vial Adapter 15mm is a single-piece molded polycarbonate device designed to facilitate the safe and efficient reconstitution and transfer of medications stored in vials.

  • In what clinical environments is this device intended to be used?

    This device is intended for use within a general hospital setting to assist clinical staff with drug transfer procedures.

  • What is the regulatory status of the Vial Adapter 15mm?

    The Vial Adapter 15mm has received FDA 510(k) clearance under the special pathway, confirming it is substantially equivalent to existing devices for its intended use.