Sodem High Speed System for Neurosurgery & Median Styernotomy

FDA 510(k) K955174 · Sodem Diffusion SA

Substantially Equivalent

510(k) numberK955174

Submission

Device name
Sodem High Speed System for Neurosurgery & Median Styernotomy
Applicant
Sodem Diffusion SA
North Attleboro, MA, US
Received
November 13, 1995
Decision date
January 22, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GET – Motor, Surgical Instrument, Pneumatic Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code GET

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K960473Aesculap Power System HandpieceGET · Traditional Aesculap, Inc.03/07/1996SE
K942987Nucleotome L KitGET · Traditional Surgical Dynamics, Inc.10/30/1995SE
K954076Midas Rex Drill Attachments & Twist DrillsGET · Traditional Midas Rex Pneumatic Tools, Inc.10/18/1995SE
K953433Midas Rex Telescoping SystemGET · Traditional Midas Rex Pneumatic Tools, Inc.09/15/1995SE
K953432Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsGET · Traditional Midas Rex Pneumatic Tools, Inc.09/14/1995SE
K952463GS & GS20 Surgical Tool SystemGET · Traditional Midas Rex Pneumatic Tools, Inc.07/17/1995SE
K952300Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional Midas Rex Pneumatic Tools, Inc.05/26/1995SE
K914753Auto Suture(R) Articulating Endoscopic ClampGET · Traditional United States Surgical, A Division of Tyco Healthc06/11/1992SE
K910071Porta Gas Compressed Gas Cylinder CartGET · Traditional Sen Tech Medical Corp.03/22/1991SE
K904578Modification Auto Suture(R) Endoscopic ClampGET · Traditional United States Surgical, A Division of Tyco Healthc10/30/1990SE

More from United States Surgical, A Division of Tyco Healthc

510(k)DeviceDecision
K954717Sodem High Speed System for Neurosurgery & Median SternotomyHBB · Traditional 01/22/1997SE
K954080Sodem High Speed SystemHSZ · Traditional 10/16/1995SE

Questions and answers

When was Sodem High Speed System for Neurosurgery & Median Styernotomy cleared by the FDA?

Sodem High Speed System for Neurosurgery & Median Styernotomy (K955174) received a 510(k) decision of Substantially Equivalent on January 22, 1996, 70 days after the submission was received.

What is the product code of K955174?

The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.