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Mani Needle & Suture Pack

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050150

by Mani, Inc.

Identifiers

510(k) Number
K050150 FDA 510(k)
FDA Product Code
GAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5000 FDA 510(k)
Regulation Number
878.5000 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mani Needle & Suture Pack is a medical device used for suturing. It is a type of device that includes a needle and suture, and is used in medical procedures.

The device is supplied as a pack, and is intended for single-use. It is available in various sizes, although specific sizes are not stated. The device has been cleared through the FDA 510K process, with a decision date of 2005-12-05 and k number K050150.

Frequently asked questions

What is the Mani Needle & Suture Pack used for?

The Mani Needle & Suture Pack is used for suturing in medical procedures, providing a convenient pack that includes a needle and suture.

Is the Mani Needle & Suture Pack supplied sterile?

The device data does not explicitly state the sterility of the Mani Needle & Suture Pack, but it is intended for single-use, implying it should be sterile to ensure patient safety.

What sizes is the Mani Needle & Suture Pack available in?

The Mani Needle & Suture Pack is available in various sizes, although specific sizes are not stated in the device data.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mani, Inc.

Sources (1)

  • FDA 510(k) K050150 24 fields · synced Sep 23, 2026