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Sterile Dressing Pack

FDA 510(k)

Class II (US FDA 510(k))

510(k) K800490

by Medi-Spec

Identifiers

510(k) Number
K800490 FDA 510(k)
FDA Product Code
KKX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A sterile dressing pack is a pre-sterilised kit designed for wound care, clinical examination, minor surgery preparation, and procedural support. It is intended to maximize the efficiency of medical staff by providing essential components in a ready-to-use format.

Supplied in boxes of 12 single-use packs, the device is intended for use in GP surgeries, clinics, home care, or pharmacies. It received FDA 510(k) clearance (K800490) on March 12, 1980, under product code KKX, and is classified as substantially equivalent to a predicate device.

Frequently asked questions

What is the sterile dressing pack used for?

The sterile dressing pack is designed for wound care, clinical examination, minor surgery preparation, and procedural support. It provides essential components in a ready-to-use format to maximize efficiency for medical staff in settings such as GP surgeries, clinics, home care, or pharmacies.

How is the sterile dressing pack supplied and is it reusable?

The device is supplied in boxes of 12 single-use packs, meaning each pack is intended for one-time use only. This ensures sterility and reduces cross-contamination risk, making it unsuitable for reuse after initial application.

What regulatory clearance does the sterile dressing pack have?

The sterile dressing pack received FDA 510(k) clearance under K800490 on March 12, 1980, and was determined to be substantially equivalent to a predicate device under product code KKX. This clearance confirms its regulatory pathway but does not indicate approval for new or unlisted uses.

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: Drug Tariff Dressing Pack (sterile) Spec 35 - Pack of 12, Sterile Dressing Pack & Kit - Winner Medical, Spec 10 & Spec 35 Sterile Dressing Packs - Drug Tariff Wound Dressing ..., Dressit - Aseptic Community Sterile Dressing Pack by Richardson Healthcare

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medi-Spec

Sources (1)

  • FDA 510(k) K800490 24 fields · synced Sep 27, 2026