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Clip 'N'ject Reconstitution System (Clip 'N'ject

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041691

by West Pharmaceutical Services, Inc.

Identifiers

510(k) Number
K041691 FDA 510(k)
FDA Product Code
LHI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Clip 'N'ject Reconstitution System (Clip 'N'ject is a device designed for the reconstitution of lyophilized medications. It is intended to facilitate the mixing of drug powder with diluent prior to administration.

The system is supplied non-sterile and is intended for single-use. It is used in general hospital settings and has received FDA 510(k) clearance under product code LHI, with K-number K041691.

Frequently asked questions

What is the Clip 'N'ject Reconstitution System used for?

The Clip 'N'ject Reconstitution System is designed to facilitate the reconstitution of lyophilized medications by enabling the mixing of drug powder with diluent prior to administration, ensuring proper preparation for patient use.

Is the Clip 'N'ject Reconstitution System sterile or non-sterile, and is it intended for single-use or reuse?

The system is supplied non-sterile and is explicitly intended for single-use only, meaning it should not be reprocessed or reused after initial application to maintain safety and functionality.

In what type of healthcare setting is the Clip 'N'ject Reconstitution System intended to be used?

The device is intended for use in general hospital settings, supporting routine medication preparation tasks where lyophilized drugs require reconstitution before delivery to patients.

What regulatory pathway was used for the Clip 'N'ject Reconstitution System, and what is its K-number?

The Clip 'N'ject Reconstitution System received FDA 510(k) clearance through a traditional submission process, with the K-number K041691, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Messesysteme mit WOW-Effekt - Clip

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
West Pharmaceutical Services, Inc.

Sources (1)

  • FDA 510(k) K041691 24 fields · synced Oct 6, 2026