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Manan Blunt Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981386

by Manan Medical Products, Inc.

Identifiers

510(k) Number
K981386 FDA 510(k)
FDA Product Code
FPA 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 Manan Blunt Needle is classified as a Blunt Needle (Product Code: FPA) under FDA nomenclature, designed for medical procedures requiring minimal tissue trauma. Its primary function is to facilitate access to internal structures while reducing the risk of accidental puncture or damage to surrounding tissues, making it suitable for applications in general hospital settings.

This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance (K981386) under the Traditional pathway. It is not MRI-safe or reusable, and no specific storage conditions are noted in the regulatory data. The device is manufactured by Manan Medical Products, Inc., and its specifications align with the General Hospital advisory committee classification.

Frequently asked questions

What is the primary purpose of the Manan Blunt Needle in medical procedures?

The Manan Blunt Needle is designed to provide access to internal structures with minimal tissue trauma, reducing the risk of accidental puncture or damage to surrounding tissues. This makes it particularly useful in procedures where precision and safety are critical, such as in general hospital settings.

Is the Manan Blunt Needle intended for reuse, or is it meant for single-use only?

The Manan Blunt Needle is explicitly intended for single-use, as confirmed by its FDA 510(k) clearance (K981386). This designation ensures patient safety and hygiene standards are maintained, as reusable devices require additional sterilization processes.

How is the Manan Blunt Needle supplied, and does it come in different sizes or models?

The regulatory data does not specify exact sizes or models of the Manan Blunt Needle, but it is supplied sterile for single-use. For precise sizing or model details, you would need to refer to the manufacturer’s product catalog or contact Manan Medical Products, Inc. directly.

Are there any special storage requirements for the Manan Blunt Needle?

The regulatory data does not mention any specific storage conditions for the Manan Blunt Needle. However, since it is sterile and intended for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.

How was the FDA clearance for the Manan Blunt Needle determined, and what does this mean for its use?

The Manan Blunt Needle received FDA clearance through the Traditional 510(k) pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness) under the General Hospital advisory committee classification. This means the FDA determined it is as safe and effective as a legally marketed device that serves the same purpose, allowing it to be legally marketed in the U.S. for its intended use.

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: Manan Medical Products, Manan Medical Products, Inc. - FDA 510 (k) Cleared Devices, 510 (k) Premarket Notification, Device Listing 2007605233 - FDA.report, Manan-Medical-Products FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Manan Medical Products, Inc.

Sources (1)

  • FDA 510(k) K981386 24 fields · synced Sep 19, 2026