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Instrument, Ultrasonic, Scalpel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990362

by Ethicon Endo-Surgery, Inc.

Identifiers

510(k) Number
K990362 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An ultrasonic scalpel is a surgical instrument that uses high-frequency vibrations to cut and coagulate tissue simultaneously. It is designed for precise dissection and vessel sealing in surgical procedures.

This device is supplied as a reusable instrument intended for use in open or laparoscopic general and plastic surgery settings. It requires connection to a compatible ultrasonic generator for operation and is not sterile upon supply, necessitating reprocessing before each use.

Frequently asked questions

What is the INSTRUMENT, ULTRASONIC, SCALPEL used for?

It is designed for precise dissection and vessel sealing in surgical procedures, using high-frequency vibrations to cut and coagulate tissue simultaneously in open or laparoscopic general and plastic surgery settings.

Is the INSTRUMENT, ULTRASONIC, SCALPEL supplied sterile or non-sterile?

The device is not sterile upon supply and requires reprocessing before each use, as it is intended to be a reusable instrument that must be cleaned and sterilized between procedures.

What is required to operate the INSTRUMENT, ULTRASONIC, SCALPEL?

It requires connection to a compatible ultrasonic generator for operation, as the high-frequency vibrations needed for cutting and coagulating tissue are generated externally by the generator unit.

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: HARMONIC™ 1100 Shears | J&J MedTech US - Johnson & Johnson Medical ..., ETHICON™ GEN11 Generator | J&J MedTech US - Johnson & Johnson Medical ..., Ethicon Gen 11 | Harmonic Scalpel ESU | AXONIA MEDICAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA 510(k) K990362 24 fields · synced Sep 27, 2026