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Percutaneous Surgical Set With 5MM Or 10MM Attachments

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN110016

by Ethicon Endo-Surgery

Identifiers

510(k) Number
DEN110016 FDA 510(k)
FDA Product Code
OXT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4805 FDA 510(k)
Regulation Number
878.4805 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
DENG FDA 510(k)

The Percutaneous Surgical Set With 5mm Or 10mm Attachments is a medical device used for percutaneous surgery. It is designed with 5mm or 10mm attachments for various surgical procedures. The device is classified as a Class 2 device and is used in general and plastic surgery. It is a type of surgical set that allows for minimally invasive surgery techniques.

The device is supplied with 5mm or 10mm attachments and is intended for single-use. It is made by Ethicon Endo-Surgery and has an FDA 510K authorization. The device is stored at the manufacturer's address in Cincinnati, OH, and has a product code of OXT. It is regulated under the regulation number 878.4805 and has a registration number of 3003744503.

Frequently asked questions

What is the Percutaneous Surgical Set used for?

The Percutaneous Surgical Set is used for percutaneous surgery, allowing for minimally invasive techniques in general and plastic surgery procedures.

Is the Percutaneous Surgical Set supplied with multiple attachment sizes?

Yes, the device is supplied with 5mm or 10mm attachments for various surgical procedures.

Is the Percutaneous Surgical Set intended for single-use or reuse?

The Percutaneous Surgical Set is intended for single-use.

What is the regulatory classification of the Percutaneous Surgical Set?

The device is classified as a Class 2 device and is regulated under the regulation number 878.4805.

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: Specialty Surgical Instruments | Ambler Surgical, Premium Surgical Supplies | STAT Surgical Supply, Progressive Medical, Inc. | National Medical Device Sales, Marketing ..., PROstep - Stryker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery

Sources (1)

  • FDA 510(k) DEN110016 24 fields · synced Sep 24, 2026